Patent Application
20250120852
Patients with minor injuries seek medical attention at primary care clinics, urgent care centers, and hospital emergency rooms. Many urgent care centers are not open twenty-four hours per day and seven days per week (24/7). Rural areas may have limited availability of these urgent care centers. A common type of visit to a hospital emergency room or urgent care center is a wound requiring cessation of bleeding, especially patients on anticoagulant or antiplatelet medications. As the population ages, more patients require these medications for a variety of conditions.
Better methods and devices are needed to allow patients, family members, and/or caretakers to safely treat at home, or at the place of the injury, minor wounds requiring the cessation of bleeding.
This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
Disclosed herein are devices, methods of using devices, and methods of making devices for treatment of bleeding, e.g. from minor wounds. In some embodiments, a system includes an applicator pad, an application device (e.g., a grip), and a reservoir. The grip can be releasably couplable to the applicator pad and configured to dispose the applicator pad against a wound of a subject such that pressure can be transferred to the wound via the applicator pad to enhance hemostasis. The reservoir can be configured to contain medication to be released to the wound via the applicator pad.
Additional features, aspects and/or advantages will be recognized and appreciated upon further review of a detailed description of the illustrative embodiments taken in conjunction with the accompanying drawings.
The detailed description herein serves to describe non-limiting embodiments or examples involving various inventive concepts and uses reference numbers for ease of understanding these examples. Common reference numbers between the figures refer to common features and structure having the same or similar functions, as will be understood. While various figures will have common reference numbers referring to such common features and structure, for purposes of conciseness, later figure descriptions will not necessarily repeat a discussion of these features and structure.
For reference,
The systems and methods described herein can be configured to treat a wound and/or assist with cessation of bleeding of a wound that extends through the epidermal and/or dermal layer, is non-arterial, is not resulting in pulsatile bleeding, and has no subcutaneous fat or muscle exposed. In some embodiments, the systems and methods described herein can be self-administered (e.g., the administrator of the system and/or method is also the subject having the wound). In some embodiments, the systems and methods described herein can be administered to a subject having a wound by a person other than the subject, such as a caregiver (e.g., a non-medical home care provider such as a family member) or clinician. In some embodiments, the systems and methods described herein can be administered to a non-human patient such as a pet dog or a pet cat, and the method steps can be performed by a pet owner or veterinarian. In some embodiments, target wounds treatable by the systems and methods described herein may be less than 3 centimeters in length. In some embodiments, target wounds treatable by the systems and methods described herein in a home use setting may be wounds not requiring stitches or sutures to close. In some embodiments, target wounds treatable by the systems and methods described herein in a clinical setting may be wounds for which bleeding can first be attempted to be stopped using the systems and methods described herein before utilizing stitches or sutures if the systems and/or methods described herein are not effective after one use.
Potential patient populations that can be treated by the systems and methods described herein include any person with topical bleeds (i.e., bleeding from the skin). For example, target patient populations can include people with naturally-induced, drug-induced, or procedurally-induced increased susceptibility to bleeding and/or resistance to blood clotting. Naturally-induced susceptibility to bleeding and/or resistance to blood clotting can arise from a chronic condition such as hemophilia, Von Willebrand disease, vascular disorders (e.g., Osler-Weber-Rendu), coagulopathies, kidney failure, liver failure, bone marrow suppression (pathologically or medication-induced) platelet disorders, age (older people can have more friable skin), or conditions (e.g., a genetic condition) that render the person more accident prone or difficult to treat (including age and/or motor or cognitive deficits). Drugs that can induce susceptibility to bleeding and/or resistance to clotting can include: anticoagulation medications such as warfarin, heparin, factor Xa inhibitor, thrombin inhibitors, low-molecular weight heparin, dabigatran, argatorban, hirudin, rivaroxaban, apixaban, edoxaban, fondaparinux, enoxaparin, dalteparin, and bivalirudin; and antiplatelet medications such as platelet aggregation inhibitors such as aspirin (acetylsalicylic acid or ASA), cangrelor, ticagrelor, lopidogrel, prasugrel, cilostazol, clopidogrel, dipyridamole, ticlopidine, glycoprotein platelet inhibitors such as epifibatide, tirofiban, abciximab, and protease-activated receptor-1 antagonists such as vorapaxar. Anticoagulation medications can be taken for a wide variety of indications, such as deep venous thrombosis, pulmonary embolus, and atrial fibrillation. Medical procedures that can induce susceptibility to bleeding and/or resistance to clotting can include renal replacement therapy (e.g., hemodialysis), cardiopulmonary bypass, extra-corporeal membrane oxygenation (ECMO), chemical thrombolysis (with tissue plasminogen activating factor (TPA)), cardiac catheterization, peripheral vascular procedures (e.g., femoral-popliteal bypass, arterial thrombectomy), mechanical thrombectomy, angiography, and other neuro-interventional procedures and interventions. In some embodiments, any of the systems, methods, or devices herein can be used to treat melasma and/or sun spots. Although systems described herein are referred to as bleeding treatment systems and described with respect to treating wounds, any of the systems and devices described herein, such as the system 100 described below, can also be configured or used as a system or device for topically applying any therapeutic or other substance to any suitable type of target treatment area of a user that may benefit from application of the substance.
A bleeding treatment system 100 that can be used to treat a wound requiring cessation of bleeding is illustrated schematically in
The applicator pad 110 (also referred to as a topical applicator pad) is sized, configured, and formed of material, suitable for covering a wound treatable by the system 100. The applicator pad 110 may be formed of any one or more materials having suitable physical properties. For example, the material is preferably capable of absorbing blood. The material may also swell or expand upon absorbing fluid such as blood. The material may also be capable of containing, absorbing, wicking, or otherwise transporting one or more medications for application to a surface of the wound WD and/or the skin SK surrounding the wound. It should be biologically compatible with the skin SK and wound WD. Preferably the one or more materials are also non-reactive, or otherwise compatible with any medication(s) to be transported by the applicator pad 110, e.g., not alter the composition, delivery, or efficacy of the medication(s) or degrade or otherwise lose any of its desired physical properties upon exposure to the medication(s) over the maximum duration of the wound treatment. The material is preferably sufficiently stiff, resilient, etc. to be capable of applying a sufficient amount of pressure against the wound treatment to aid in achieving hemostasis, i.e., function as a hemostat. At least a bottom or distal surface of the applicator pad 110 (e.g., any surface exposed prior to use of the bleeding treatment system 100) can be covered or enclosed by the removable applicator seal 120 to prevent contamination of the applicator pad 110 and/or prevent undesired release of any medication(s) that may be contained in the applicator pad 110. The applicator pad 110 can be formed of a sponge material. The applicator seal 120 can be formed as a film or other thin layer of material non-reactive with the applicator pad 110. The applicator seal 120 can be removed from the applicator pad 110 prior to use (e.g., via peeling).
Suitable materials for the applicator pad 110 include polymers or other compositions, such as polyvinyl alcohol (PVA), polyurethane (hydrophilic or otherwise), polypropylene, which may be formed into foams (open or closed cell) (e.g., a porous expandable foam), natural fibers such as cotton, linen, wool, etc. in woven or non-woven (e.g. felt) form, and/or layered matrices of foam and/or gauze packing. The applicator pad 110 may be formed monolithically of a single material, or may be formed as a composite or other aggregation of different materials. For example, the applicator pad 110 may be primarily formed of one material, and have a relatively thin covering of a second material. The materials may achieve the desired functions in different ways. For example, absorption of blood may be achieved mechanically, e.g. by capillary wicking, and/or chemically, such as by absorption into, for example, molecular sieves or other desiccants, or combination with materials such as clays, e.g. kaolin, bentonite, montmorillonite, saponite, polygorskite, attapulgite, and/or sepiolite. In some embodiments, clay may be dispersed in a liquid medium. In some embodiments, the applicator pad 110 can include a hemostatic patch and a flexible insulating or wicking mechanism (also referred to as a backing portion or layer). In some embodiments, the hemostatic patch can include liquid medication, and the flexible insulating or wicking mechanism can isolate a hand applying pressure to the applicator pad 110 from the wound site and the liquid medication.
As explained in more detail below, the applicator pad 110 may include, incorporate, or embody a reservoir for medication(s), and a different material may be used to form or bound such a reservoir. In some embodiments, the applicator pad 110 can include a reservoir for dry or lipophilized medication that may be made flowable via fluid released from a reservoir of the applicator device 170 and/or blood from the wound. For example, the applicator pad 110 and/or a backing layer coupled to the applicator pad 110 can define a recessed or internal area within which powdered medication can be disposed in an initial configuration of the applicator pad 110. In some embodiments, the applicator pad 110 can define or include internal structures or passages to aid flow of medication through the applicator pad 110 and/or preferentially direct flow toward target wound tissue. In some embodiments, the applicator pad 110 can include a colored dye.
The bleeding treatment system 100 is preferably configured to deliver one or more medications to target wound tissue during treatment, e.g., via the applicator pad 110. The medication(s) may be contained in one or more reservoirs 150 (which, as noted above, may be separate from or incorporated into the applicator pad 110), may be selectively released from the reservoir(s) 150 by one or more release mechanisms 160, and may be conveyed from the reservoir(s) 150 to the applicator pad 110 by one or more fluid couplings 155. For example, the reservoir 150 may be implemented as a container (ampoule or the like) having a volume sufficient to contain a therapeutically effective amount of the medication and formed of material impermeable to, and non-reactive with, the medication or its constituents, such as glass, metal, plastic, polymer (e.g., a rigid polymer such as polyethylene, polypropylene, polyamide, polycarbonate), etc. In some embodiments, the reservoir 150 may be formed of a material that can be broken or punctured to release the contents of the reservoir 150 (e.g., plastic or glass). The reservoir 150 may have an opening through which the medication can be introduced into the reservoir 150 and/or selective selectively released therefrom. In some embodiments, the reservoir 150 can include a vent.
The grip portion 140 can be formed of any suitable material, with at least the distal end (e.g., the optional plate) being formed of a relatively rigid material capable of applying suitable pressure to the applicator pad 110. For example, the grip portion 140 (or at least a body of a first portion of the grip 140) can be formed of a rigid polymer such as polyethylene, polypropylene, polyamide, and/or polycarbonate.
The reservoir 150 may be contained, in whole or in part, within the applicator pad 110, or may be coupled thereto via a fluid coupling 155, such as a tube, wick, etc. The medication(s) may be selectively released from the reservoir 150 so that the medication(s) can be received in the applicator pad 110, e.g. by the release mechanism 160. The release mechanism 160 may be, for example a valve, which may be opened to establish fluidic communication between the reservoir 150 and the applicator pad 110, directly or via fluid coupling 155, and may also be selectively closed to fluidically isolate the medication(s) in the reservoir 150. The release mechanism 160 may be a removable or frangible cap or other closure closing an opening in reservoir 150. The reservoir 150 may itself be frangible, e.g., formed of glass that may be readily broken or at least partially of a material that bursts when the contents of the reservoir 150 are above a threshold pressure, and the medication(s) can be released from the reservoir 150 by causing or allowing the reservoir 150 to be broken. As noted above, in some embodiments the reservoir 150 may be a part of the applicator pad 110. For example, the material of the applicator pad 100 may be soaked or saturated with medication(s), and enclosed with the applicator seal 120 (e.g., a film or other thin layer of material impermeable to and non-reactive with the medication(s)). The medication(s) can be released from the reservoir 150 by removing the applicator seal 120, exposing the surface of the applicator pad 110 so that the medication(s) can be delivered to the wound tissue with which the surface of the applicator pad 110 is placed in contact.
In some embodiments, volume and material of the applicator pad 110 can be selected such that the amount of medication(s) contained in one or more reservoirs 150, whether separate from the applicator pad 110 or incorporated into the applicator pad 110, or the amount of medication(s) can be pre-soaked into the applicator pad 110 such that the applicator pad 110 is about 35% saturated (i.e., contains about 35% of the amount of the medication(s) that it is capable of containing). In some embodiments, the applicator pad 110 can be configured to be between about 67 and about 100% saturated by the amount of medication(s). In some embodiments, the applicator pad 110 is configured to be between about 25 and about 50% saturated by the amount of medication(s). In some embodiments, the applicator pad 110 can be pre-soaked or filled to hold a metered dose of medication. In some embodiments, the applicator pad 110 can be configured such that the volume of medication(s) is effective to treat the wound but such that the medication does not travel across the user's skin outside of the treatment area (e.g., down a user's arm or leg) (e.g., configured to be about 35% saturated or between about 25% and about 50% saturated).
The applicator pad 110 can be any suitable shape and/or size that is, preferably, sufficient to cover the target wound. For example, the perimeter of the applicator pad 110 can be formed as a circle, an oval, an ellipse, a square, a rounded square, a rectangle, a rounded rectangle, a triangle, a pentagon, a hexagon, or any other suitable shape. As described above, target wound sizes to be covered by the applicator pad 110 may be, for example, less than about 3 centimeters in length and/or width. In some embodiments, for example, the applicator pad 110 can have a square perimeter having side lengths of about 1.5 inches. In some embodiments, the applicator pad 110 can have a smaller area. In some embodiments, the applicator pad 110 can have a surface area between about 3.0 cm2 and about 7.0 cm2. In some embodiments, the applicator pad 110 can have a surface area between about 7.0 cm2 and about 12.0 cm2. In some embodiments, the applicator pad 110 can have a surface area of between about 2 cm2 and about 25 cm2. In some embodiments, the applicator pad 110 can have a surface area between about 3 cm2 and about 10 cm2 or between about 10 cm2 and about 20 cm2. For example, the surface area may be about 2 cm2, about 3 cm2, about 4 cm2, about 5 cm2, about 6 cm2, about 7 cm2, about 8 cm2, about 9 cm2, about 10 cm2, about 11 cm2, about 12 cm2, about 13 cm2, about 14 cm2, about 15 cm2, about 16 cm2, about 17 cm2, about 18 cm2, about 19 cm2, about 20 cm2, about 21 cm2, about 22 cm2, about 23 cm2, about 24 cm2, or about 25 cm2.
The applicator device 170 may be any suitable device manipulable by a user to dispose the applicator pad 110 into a desired location, e.g., adjacent a wound WD, and to deposit the applicator pad 110 in the desired location. For example, the applicator device 170 may be a mechanical syringe that includes a barrel having a distal end suitable for attachment to the applicator pad 110 and a proximal end that may be grasped by the user. In some embodiments, the reservoir 150, the release mechanism 160, and/or the fluid coupling 155 can be disposed within the barrel (e.g., between a plunger and the applicator pad 110). In some embodiments, the applicator device 170 can include a plunger movable relative to the barrel and to which a user can apply distally directed force to engage the distal end of the plunger with the reservoir 150 and to cause the contents of the reservoir 150 to be urged distally through the barrel, out of the distal end of the barrel, and into contact with the applicator pad 110. For example, the reservoir 150 can include a breakable neck portion that separates from a body portion of the reservoir 150 to release liquid from the reservoir 150 in response to the reservoir 150 being urged against an internal ramp or incline. As another example, a neck portion of the reservoir 150 can be broken from the reservoir due to engagement between a deformable sidewall of the applicator device 170 and the neck portion due to manipulation of the sidewall by a user.
In some embodiments, the reservoir 150 can include a weakened or pre-scored area (e.g., a circumferential region or sidewall region) configured to preferentially break when a breaking force is applied to the weakened or pre-scored area. For example, in some embodiments, the weakened or pre-scored area can be at a mid-point location of the reservoir 150 along a central axis of the reservoir 150, adjacent a shoulder of the reservoir 150, and/or can be on or near a first (e.g., a distal) or a second (e.g., a proximal) end of the reservoir 150. The reservoir 150 can be configured to break (e.g., at a weakened or pre-scored area) due to a rotational, bending, and/or orthogonal force (relative to or along the central axis of the reservoir 150) applied to the reservoir 150. In some embodiments, such a rotational, bending, and/or orthogonal force can be applied via twisting and/or bending the grip 140 within which the reservoir 150 is disposed. In some embodiments, the breaking force can be applied via displacing (e.g., squeezing) a portion of the grip (e.g., a deformable sidewall portion) into sufficiently forceful contact with a sidewall of the reservoir 150 to break the reservoir 150 and release the contents of the reservoir 150. In some embodiments, the breaking force can be applied via rotating or translating a second portion of the grip 140 relative to a first portion of the grip 140 to apply the breaking force to the reservoir 150.
In some embodiments, the release mechanism 160 can include a force concentrating component (also referred to as a stress concentrating component) (e.g., a ball such as a steel ball or projection such as a convex or sharp tipped projection like a carbide tip) disposed on an inner surface of the grip 140 and configured to be urged toward a sidewall of the reservoir 150 (e.g., as a result of bending of the grip 140, squeezing or pushing an exterior portion of the grip 140 toward the reservoir 150, or rotating a second portion of the grip 140 relative to a first portion of the grip 140) to concentrate a breaking force against a sidewall or end of the reservoir 150 and break (e.g., shatter) the reservoir 150. In some embodiments, the grip 140 can include a notched feature in a sidewall of the grip 140 such that the grip 140 can be more easily bent about a preferential axis or plane including the notched feature.
In some embodiments, the reservoir 150 and/or the grip 140 can be disposed in a vertical orientation during a wetting of the applicator pad 110 with the contents of the reservoir 150 and/or during application of pressure to the applicator pad 110 when disposed on a wound of the subject such that the reservoir 150 is elongated along a longitudinal axis intersecting a plane containing the applicator pad 110 in the initial configuration of the system 100. In some embodiments, the contents of the reservoir 150 can be configured to flow from the reservoir 150 to the applicator pad 110 through an open distal end of the grip 140. In some embodiments, the reservoir 150 and/or the grip 140 can be disposed in a horizontal orientation during a wetting of the applicator pad 110 with the contents of the reservoir 150 and/or during application of pressure to the applicator pad 110 when disposed on a wound of the subject such that the reservoir 150 is elongated along a longitudinal axis disposed substantially parallel to a plane containing the applicator pad 110 in the initial configuration of the system 100. In some embodiments, the contents of the reservoir 150 can be configured to flow from the reservoir 150 to the applicator pad 110 through a sidewall of the grip 140.
In some embodiments, the applicator device 170 can include a filter (not shown) between the reservoir 150 and the applicator pad 110 to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 110. In some embodiments, the applicator device 170 may not contain the reservoir 150, the release mechanism 160, and/or the fluid coupling 155, but instead just provide a handle by which the user may hold the applicator pad 110 to be able to apply the applicator pad 110 to the target wound tissue and apply distributed pressure to the applicator pad 110 to maintain pressure between the applicator pad 110 against the target wound tissue.
The grip 140 may be used to provide a distributed force (e.g., a uniformly distributed force) to the applicator pad 110, e.g., to increase the pressure that the applicator pad 110 may apply to target wound tissue during use, to enhance hemostasis. The grip 140 may be implemented in a variety of ways, including those described in specific embodiments below. For example, the grip 140 may include a plate (also referred to herein as a “fixation plate”) disposed on a distal end of and extending laterally from a handle portion of the grip 140 and configured to contact and apply a distributed force against the applicator pad 110. In some implementations, the plate can be shaped and sized such that the plate has a larger length and width than the target wound tissue such that the plate can urge a sufficiently large portion of the applicator pad 110 into contact with the target wound tissue and maintain uniformly distributed pressure between the applicator pad 110 and the target wound tissue for a period of time. Thus, the grip 140 can be used to provide a sufficient hemostatic force against the target wound tissue (e.g. to generate sufficient pressure given the stiffness or modulus of the material(s) of which the applicator pad 110 is formed). In some embodiments, the grip 140 or a portion of the grip may be deformable (e.g., squeezable) to urge fluid from the reservoir 150 disposed within the grip.
In some embodiments, the applicator device 170 can selectively release the applicator pad 110. For example, the grip 140 can releasably engage with the applicator pad 110 via the pad connector 148 to apply the applicator pad 110 to a surface of the patient (e.g., to the target wound tissue). The pad connector 148 can disengage from the applicator pad 110 such that the grip 140 and pad connector 148 can be separated from the applicator pad 110, leaving the applicator pad 110 on the surface of the patient. In some embodiments, the pad connector 148 can include one or more adhesive strips configured to couple the grip 140 to the applicator pad 110 and to be removed from the grip 140 and/or the applicator pad 110 when the applicator pad 110 is disposed in contact with the wound of the subject without displacing the applicator pad 110 relative to the wound such that the grip 140 can be separated from the applicator pad 110 without displacing the applicator pad 110 relative to the wound. In some embodiments, the pad connector 148 can include complementary hook-and-loop fastener portions coupled to the grip 140 and the applicator pad 110 such that the grip 140 can be releasably coupled to the applicator pad 110 via decoupling the complementary hook-and-loop fastener portions. In some embodiments, the pad connector 148 can include a first engagement feature coupled to the applicator pad 110 and a second complementary engagement feature coupled to the grip 140. The second complementary engagement feature can be configured to releasably engage with the first engagement feature (e.g., via receiving a portion of the first engagement feature within an opening of the second engagement feature due to, for example, relative rotation between the features, or via receiving a portion of the first engagement feature between opposing arms of the second engagement feature). In some embodiments, the pad connector 148 can include a latch portion disposed on the grip 140 configured to engage with a hook portion disposed on the applicator pad 110.
In some embodiments, the applicator pad 110 can include or be coupled to the pad retainer 135, which can be configured to maintain the applicator pad 110 in contact with the target wound tissue. The pad retainer 135 can include, for example, adhesive on a skin-contacting side of the applicator pad 110 (e.g., disposed around at least a portion of a perimeter of the applicator pad 110). In some embodiments, the pad retainer 135 can include an adhesive foam disposed about a perimeter of the applicator pad 110. In some embodiments, the pad retainer 135 can include adhesive strips having a first portion coupled to an upper surface of the applicator pad 110 and having a second portion configured to be coupled to a subject's skin to retain the applicator pad 110 in place relative to a wound on the skin. In some embodiments, the pad retainer 135 can include a bandage configured to be placed over at least a portion of the applicator pad 110. In some embodiments, the bandage can be formed as a wrap configured to be wrapped around a portion of the subject's body including the wound (e.g., an arm or a leg). In some embodiments, the bandage can be formed as a bandage having an adhesive perimeter greater than the perimeter of the applicator pad 110 and configured to be applied over the top of the applicator pad 110. In some embodiments, the bandage can include a convex portion configured to be aligned with the wound and placed in contact with the upper surface of the applicator pad 110 such that, when the applicator pad 110 is disposed on the wound and the bandage is applied over the applicator pad 110, the convex portion can apply targeted pressure to the wound via the applicator pad 110 that is greater than if the bandage did not include a convex portion. In some embodiments, after a period of time, the convex portion can be removed from the subject, leaving the applicator pad 110 in place in contact with the wound.
In some embodiments, the applicator device 170 can be implemented as a pipette. The pipette may be configured in a manner most suitable for the accuracy and precision needed for the size and location of the wound. For example, the pipette may be configured to be positioned within a patient's nostril.
The bleeding treatment system 100 may include a user guide 190. The user guide 190 may include instructions for operation of the bleeding treatment system 100 to treat a person experiencing a wound requiring cessation of bleeding. The instructions may be in the form of textual and/or graphical information, which may be presented on fixed substrate (e.g. paper) or on a display (e.g. screen), and/or may use other sensory modalities, including audible (spoken instructions) and/or tactile (haptic feedback to the user). The user guide 190 may be disposed on (e.g. printed on) or coupled to (e.g. mechanically attached) any one or more component(s) of the bleeding treatment system 100, including the applicator device 170, the packaging 190, the applicator pad 110, and/or the reservoir 150. The user guide 190 may be separate from any of the components of the bleeding treatment system 100, but may be associated therewith, e.g. disposed in the packaging 195 along with the other components of the bleeding treatment system 100. In some embodiments, the user guide 190 may be implemented in whole or in part in software usable on a device such as smart phone, e.g. may be the form of an “app” that can be downloaded onto the smart phone and launched by a user in preparation for using the bleeding treatment system 100.
In some embodiments, the user guide 190 or another informational label disposed on or included with the system 100 can include an information label including user instructions such as: “Only apply only to superficial bleeding areas less than 1 inch. Press down with the topical applicator pad over the wound for 5 minutes. Place an adhesive bandage over the wound. If bleeding does not stop, seek professional medical treatment. If you feel weak or dizzy, call 911 immediately and do not use this device. Not to be used in the mouth. Not to be used on deep wounds. Do not use if you have a history of seizures. Do not use for penetrating wounds or puncture wounds (gunshot, knife, etc.).”
In some embodiments, the user guide 190 or another informational label disposed on or included with the system 100 can include an information label including user instructions such as: “Only apply only to superficial bleeding wounds 3 inches or less in length. Push the release mechanism to break the medication. Allow the medication to fully cover the topical applicator. Press down with the device over the wound for 10 minutes. Place an adhesive bandage over the wound. If bleeding does not stop or if you feel dizzy, weak, or fatigued, seek professional medical treatment IMMEDIATELY. Not to be used in the mouth. Not to be used on deep wounds. Do not use if you have a history of seizures. Do not use for penetrating wounds or puncture wounds (gunshot, knife, etc.). Do not drink this medication. Keep away from children or infants.”
In some embodiments, the user guide 190 or another information label disposed on or included with the system 100 can include one or more statements indicating one or more of the following: (i) remove the applicator cap before pressing down with the device over the wound; and (ii) peel the topical applicator from the rest of the device and use an adhesive bandage to keep the topical applicator on the wound.
In some embodiments, the user guide 190 or another informational label or stamp on the system 100 can include an expiration date. For example, the system 100 may have a shelf life from a date of manufacture of three years, more than three years, or less than three years. In some embodiments, the user guide 190 or another informational label or stamp on the system 100 can include a lot number and/or a date of manufacture. In some embodiments, the user guide 190 or another informational label or stamp on the system 100 can include a bar code and/or Quick Response (QR) code.
The packaging 195 may be implemented in the same manner as any known medical device packaging, to contain the other components of the bleeding treatment system 100, to protect the components from the environment, and optionally to preserve sterility of the components. The packaging 195 is preferably configured to be readily opened by a user, e.g. by peeling a cover from a tray, when the user desires to access and use bleeding treatment system 100. The packaging 195 may be implemented in many other ways, including for example a bag or box. The system 100 is preferably intended for a single user and one wound site application. The system 100 is preferably intended to be discarded after use, and may optionally include a container for safe disposal. In some embodiments, the system 100 can be originally supplied to the user in the packaging 195 that can also be used for disposal. In some embodiments, the packaging 195 and/or disposal container can be a re-sealable bag and/or can include a biohazard label and/or disposal instructions.
The medication(s) described herein may be any medication that would be desirable to deliver to the patient experiencing a wound requiring cessation of bleeding, preparatory to or as part of treatment of the wound. Categories of medications may include vasoconstrictors, antifibrinolytics, antibiotics, recombinant clotting factor medications, local anesthetics, analgesics, buffering agents, calcium, alcohols/antiseptics (e.g., a chlorhexidine solution such as a solution of chlorhexidine and isopropyl alcohol and/or ethyl alcohol), or any combination thereof. A vasoconstrictor may be useful to help bleeding vessels constrict prior to or simultaneously with administration of a hemostatic medication such as an antifibrinolytic, and may desirably be delivered to the target wound tissue at or around the site of the bleeding before, during, and/or after application of applicator pad 110 to the target wound tissue. Suitable vasoconstrictors may include phenylephrine, oxymetazoline (Afrin), and epinephrine. An antifibrinolytic agent may be useful to prevent blood clot breakdown, and may also desirably be delivered to the wound tissue at or around the site of the bleeding before, during, and/or after application of applicator pad 110 to the target wound tissue. Suitable antifibrinolytics may include aminocaproic acid, tranexamic acid (TXA) (e.g., dry or lyophilized TXA or a liquid formulation including TXA), aprotinin, protaaminomethylbenzoic acid, and fibrinogen. Protamine, a reversal agent for the anticoagulant heparin could be used before, during, or after use of the above medications. The medication(s) can include, for example, protamine sulfate. As noted above, the bleeding treatment system 100 and medication(s) may be particularly helpful for treatment of patients who are susceptible to bleeding or for whom it may be difficult to achieve hemostasis, such as patients who are taking anticoagulation and/or antiplatelet medications (identified above).
In some embodiments, the medication can include a pharmaceutical composition including a therapeutically effective amount of TXA, one or more antibiotic(s), one or more anesthetic(s), one or more non-steroid anti-inflammatory drug(s), and/or an excipient or carrier that facilitates local administration. For example, in some embodiments, the therapeutically effective amount of tranexamic acid is between 1-70% by weight of the composition. In some embodiments, the one or more antibiotic(s) can include sulfacetamide, mupirocin, erythromycin, clindamycin, sulfadiazine, mafenide, tetracycline, bacitracin, neomycin, and polymyxin B. In some embodiments, the one or more antibiotic(s) can include bacitracin, neomycin, and polymyxin B. In some embodiments, the excipient or carrier permits the composition to remain in contact with a bleeding wound. In some embodiments, the excipient or carrier comprises an ointment, a cream, a liniment, a paste, a lotion, a gel, a hydrogel, a liposome, a spray, an aerosol, a solution, or an emulsion. In some embodiments, the excipient or carrier permits instillation of the composition. In some embodiments, the one or more anesthetic(s) can include lidocaine, proparacaine, procaine, tetracaine and combinations thereof. In some embodiments, the one or more non-steroid anti-inflammatory drug(s) can include ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac and/or combinations thereof.
In some embodiments, the medication can include a TXA-containing composition. In some embodiments, the TXA-containing composition comprises about 200-300 mg/mL of TXA. In embodiments, the TXA-containing composition comprises about 200 mg/mL of TXA. In embodiments, the TXA-containing composition comprises about 300 mg/mL of TXA. In embodiments, the TXA-containing composition comprises about 250 mg/mL of TXA. In embodiments, the viscosity of the TXA-containing composition is from about 1 to 50 cps, wherein the viscosity is measured at 21° C. using the rotational viscosity Method III (Cone-and-Plate Rheometers) described in USP <912>. In embodiments, the viscosity of the TXA-containing composition is from about 1 to 100 cps, wherein the viscosity is measured at 21° C. using the rotational viscosity Method III (Cone-and-Plate Rheometers) described in USP <912>. In embodiments, the viscosity of the TXA-containing composition is from about 5 to 50 cps, wherein the viscosity is measured at 21° C. using the rotational viscosity Method III (Cone-and-Plate Rheometers) described in USP <912>. In some embodiments, the medication can include any of the compositions and/or a composition having any of the characteristics described in International Patent Application No. PCT/US2023/063500 to M. Powell et al., filed Mar. 1, 2023, entitled “Topical Tranexamic Acid Compositions and Methods of Use Thereof,” the disclosure of which is incorporated by reference herein in its entirety.
In some embodiments, the medication can include analgesics, including but not limited to, opiates such as codeine, morphine, oxycodone, etc.; acetaminophen; anti-inflammatory agents, including nonsteroidal anti-inflammatory drugs, aspirin, etc.; antibiotics or another antimicrobial drugs or compounds; antihistamines (e.g., cimetidine, chloropheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride); antifungal agents; ascorbic acid; rutin; thrombin; botanical agents; etc.; and combinations thereof. The medication can also include magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, and combinations thereof.
In some embodiments, the medication can include sterile water and/or normal saline (which can be included as a carrier). In some embodiments, the medication can include between about 50% and about 100% tranexamic acid and between about 50% and about 0% sterile water or normal saline. In some embodiments, the medication can include between about 10% and about 50% tranexamic acid and between about 90% and about 50% sterile water or normal saline. In some embodiments, the medication can include between about 50% and about 90% tranexamic acid and between about 10% and about 50% sterile water or normal saline. In some embodiments, the medication can include at least one of a liquid and a gel. In some embodiments, the medication can have a viscosity between about 0.75 millipascal-seconds and about 0.98 millipascal-seconds at about +25 degrees Celsius.
In some embodiments, the reservoir 150 can include an activation liquid such as sterile water or saline and the applicator pad 110 can include a dried (e.g., lyophilized) medication configured to be activated by the activation liquid upon release of the activation liquid from the reservoir 150. In some embodiments, the applicator pad 110 can include dried medication configured to be activated by blood flowing from the wound when the applicator pad 110 is disposed in contact with the wound such that activation liquid disposed within the applicator device 170 is not needed or is supplemental. In some embodiments, the applicator pad 110 can include wetting agents to promote dissolution of the dried medication.
In some embodiments, the medication(s) may comprise an antifibrinolytic in an amount of about 50 mg/mL to about 300 mg/mL, including about 50 mg/mL, about 100 mg/mL, about 150 mg/mL, about 200 mg/mL, about 250 mg/mL, or about 300 mg/mL. In some embodiments, the medication(s) may also include a colored dye to indicate that the medication(s) has been dispensed to the wound and is of a composition to be human viewable based on skin color and blood color (before and after clotting). In other embodiments, the medication(s) may not contain a colored dye.
In some embodiments, the amount of medication(s) (e.g., of an antifibrinolytic such as TXA) included in the reservoir and/or provided from the reservoir to the target wound (e.g., the therapeutically effective amount) can be between about 1 mg and about 20 mg, between about 1 mg and about 5 mg, between about 5 mg and about 10 mg, between about 10 mg and about 15 mg, between about 15 mg and about 20 mg, and/or between about 10 mg and about 20 mg. In some embodiments, a larger amount of medication(s) can be included for treatment of larger target wound sizes.
In some embodiments, the reservoir(s) 150 and/or release mechanism 160 are configured such that a metered dose can be provided from the reservoir (e.g., to the applicator pad 110 and/or to the patient). The metered dose (e.g., of IV TXA) can be the amount of liquid disposed within the reservoir(s) 150 prior to use of the system 100. In some embodiments, the metered dose can be between about 1.5 mL and about 2.5 mL, between about 2.5 mL and about 4.5 mL, between about 3 mL and about 10 mL, between about 3 mL and about 7 mL, between about 1 mL and about 20 mL, between about 1 mL and about 1.5 mL, between about 2.5 mL and about 5 mL, between about 5 mL and about 10 mL, between about 10 mL and about 15 mL, or between about 15 mL and about 20 mL. For example, the reservoir 150 can include a metered dose of about 1 mL, or about 2 mL, or about 3 mL, or about 4 mL, or about 5 mL, or about 6 mL, or about 7 mL, or about 8 mL, or about 9 mL, or about 10 mL, or about 11 mL, or about 12 mL, or about 13 mL, or about 14 mL, or about 15 mL, or about 16 mL, or about 17 mL, or about 18 mL, or about 19 mL, or about 20 mL.
A method of using bleeding treatment system 100 to treat a wound requiring cessation of bleeding is shown in
As shown in the flow chart of a method 200 shown in
The applicator pad 110 can be pressed, at 212, against the wound WD in the skin SK. For example, the applicator pad 110 can be pressed against the wound WD in the skin SK via applying pressure (e.g., pressure distributed across the wound WD) to the applicator pad 110 using the grip 140. Alternatively or additionally, in some embodiments, the applicator pad 110 can be pressed against the wound WD in the skin SK via the applicator pad 110 via applying pressure to the applicator pad 110 with fingers of the user.
Medication(s) can be allowed to be released, at 214, from the applicator pad 110 to the wound WD. For example, in some embodiments, medication(s) can be released from the reservoir 150 via interaction with the release mechanism 160 such that the medication(s) flow to the applicator pad 110 via the fluid coupling 155 and then from the applicator pad 110 to the wound WD. In some embodiments, as described above, the applicator pad 110 may include medication(s) prior to use of the system 100 (e.g., via being pre-soaked), such that removal of the applicator seal 120 and application of the applicator pad 110 to the wound WD (and/or pressure applied to the applicator pad 110 when in contact with the wound WD) allows or causes medication(s) to travel into contact with the wound WD. In some embodiments, rather than or in addition to releasing medication(s) from the reservoir 150, an activation liquid such as saline can be released from the reservoir 150 to activate medication(s) included in the applicator pad 110 (e.g., in an initial dry state) such that the combination of medication(s) from the applicator pad and the activation liquid can flow into contact with the wound WD. In some embodiments, blood from the wound WD can contact and activate medication(s) in the applicator pad 110 (e.g., in an initial dry state) such that the combination of medication(s) from the applicator pad and the blood can flow into contact with the wound WD.
The applicator pad 110 can be maintained, at 216, against the wound WD with pressure applied by the grip 140 against the wound WD. At 218, hemostasis can be evaluated. For example, a hemostasis condition of the wound WD can be evaluated to determine if the hemostasis condition meets a target hemostasis condition. The hemostasis condition of the wound WD can be evaluated via any suitable method. For example, after a preset period of time (e.g., five or ten to thirty minutes), the applicator pad 110 can be removed and the wound WD checked to determine whether or not hemostasis has been achieved.
In some embodiments, after evaluating hemostasis at 218, the applicator pad 110 can continue to be maintained, at 220, against the wound WD while continuing to apply pressure to the wound WD and hemostasis can be reevaluated until achieved. For example, if the hemostasis condition of the wound WD fails to meet a target hemostasis condition, the applicator pad 110 can be maintained against the wound WD applying pressure to the wound WD for a period of time. The hemostasis condition can then be reevaluated to determine if the target hemostasis condition has been met. Such a cycle can continue until the target hemostasis condition has been met, at which time the applicator pad 110 can be removed from the wound WD.
In some embodiments, as illustrated in
The first portion 342 can be formed in any suitable shape. For example, the first portion 342 can include a cylindrical or tubular housing. In some embodiments, the first portion 342 can include or be coupled to a plate 341 disposed at the distal end of the first portion 342 and configured to apply pressure to the applicator pad 310 and thus a target wound. The plate 341 may form a bottom surface of the grip 340. In some embodiments, such as when the grip 340 does not include a reservoir, the plate 341 can be formed as a continuous plate. In some embodiments, the plate 341 may be formed as a flange (e.g., a circumferential flange) extending from a bottom edge of the first portion 342.
In some embodiments, the grip 340 includes an applicator seal 320 configured to cover at least the distal or skin-contacting surface of the applicator pad 310 to prevent contamination of the applicator pad 310 and, optionally, leakage from or drying of the applicator pad 310 prior to use. The applicator seal 320 can be formed, for example, as a film (e.g., a peelable film). In some embodiments, the applicator seal 320 can be formed of a shrink wrap material covering the distal end of the applicator pad 310 and positioned over at least a portion of the length of the first portion 342.
The applicator pad 310 can be the same or similar in structure and/or function to any of the applicator pads described herein. For example, the applicator pad 310 can include and/or be coupled to an optional blood absorption pad 330 and/or an optional pad retainer 335. The blood absorption pad 330 and the pad retainer 335 can be the same or similar in structure and/or function to any of the blood absorption pads or pad retainers, respectively, described herein.
As shown in
In some embodiments, the delivery device 370 can include an optional second portion 344 (also referred to as a “second section”). In some embodiments, the second portion 344 can be configured to engage with the reservoir 350 and/or the release mechanism 360 to initiate transfer of liquid from the reservoir 350 to the applicator pad 310. In some embodiments, the second portion 344 can be formed as a plunger and advanced by a user (e.g., a self-administering home user, a caregiver, or a patient) relative to the first portion 342 (e.g., at least partially into the interior space 343 or while in contact with the reservoir 350 to advance the reservoir 350 itself) to apply pressure to the reservoir 350. In some embodiments, the second portion 344 can be disposed on a sidewall of the first portion 342 and configured to be urged laterally into the interior space 343 to apply pressure to the reservoir 350.
In some embodiments, the interior space 343 can be at least partially defined by an inner surface of a sidewall of the grip 340, and can be defined by the first portion 342 and/or the second portion 344. In some embodiments, the inner surface and/or the outer surface of the sidewall of the grip 340 (including the first portion 342 and the second portion 344) can have any suitable shape, such as a circular cylindrical shape, an oval cylindrical shape, an elliptical cylindrical shape, a tubular shape having two opposing flat sides coupled together by two opposing curved sides, and/or a prism shape, including a cube, rounded square prism, rectangular prism, rounded rectangular prism, triangular prism, pentagonal prism, hexagonal prism, etc. In some embodiments, the inner surface of the grip 340 defining the interior space 343 includes one or more rounded or beveled edges. In some embodiments, the inner surface of the grip 340 defining the interior space 343 includes a rounded rectangular prism shape with one or more rounded edges. In some embodiments, the interior space 343 is cylindrical.
In some embodiments, the release mechanism 360 can be coupled to the reservoir 350 and configured to transition from a closed condition to an open condition to allow medication to flow from the reservoir 350 and to the applicator pad 310 via the fluid coupling 355 in response to a pressure above a threshold pressure within the reservoir 350 (e.g., applied by the distal end of the second portion 344). For example, in some embodiments, the release mechanism 360 can include a weakened or frangible portion of a sidewall of the reservoir 350. In some embodiments, the release mechanism 360 includes a valve that transitions from a closed to an open condition upon an internal pressure of the reservoir 350 rising above a threshold pressure. In some embodiments, the release mechanism 360 can be a frangible portion of the reservoir 350 configured to break when pushed against an internal obstruction (not shown) such as a ramp portion within the interior space 343 such that the medication within the reservoir 350 can be released from the reservoir 350. In some embodiments, the first portion 342 can include a filter (not shown) between the reservoir 350 and the applicator pad 310 to prevent unwanted material from reaching the applicator pad 310.
Prior to use, the applicator device 370 can be disposed in an initial configuration. In the initial configuration, the applicator pad 310 can be coupled to the distal end of the grip 340. The applicator seal 320 can cover the applicator pad 310. To use the applicator device 370, the applicator seal 320 can be optionally removed and the grip 340 can be used to apply the applicator pad 310 to a wound. In embodiments including the reservoir 350, the release mechanism 360, and the fluid coupling 355, liquid (e.g., medication and/or activating agent such as saline) can be contained within the reservoir 350 prior to and optionally after applying the applicator pad 310 to the wound. To release the liquid from the reservoir 350 such that the liquid flows to the applicator pad 310, the second portion 344 can be configured to be moved relative to the first portion 342 (e.g., via translation relative to the first portion 342, radial movement relative to the first portion 342, and/or rotational movement relative to the first portion 342) to engage with the reservoir 350 and/or the release mechanism 360.
The applicator pad 310 can optionally be pressed against target wound tissue using the grip 340. The applicator pad 310 can optionally be maintained relative to the wound (e.g., without maintaining the grip 340 against the applicator pad 310) via coupling the applicator pad 310 to the skin via the pad retainer 335. The applicator pad 310 can be optionally separated from the applicator pad 310 via releasing the applicator pad 310 from the pad connector 348.
The first portion 442 can include a plate 431 having a distal or bottom surface extending laterally relative to the central axis A of the grip 440. The applicator pad 410 can be disposed on a distal end of the first portion 442 (e.g., coupled to the distal surface of the plate 431). The first portion 442 can include a ramp portion 462 (also referred to as a first release mechanism portion) extending partially into the interior space 443 of the first portion 442 such that the neck portion 452 can contact the ramp portion 462. The first portion 442 can also include one or more retaining portions 447 (e.g., flexible tab or bump portions) extending toward the central axis A of the first portion 442 and configured to contact a shoulder of the body portion 454 of the reservoir 450 as shown in
The second portion 444 can include a projection 464 (also referred to as a second release mechanism portion). The first portion 442 and the second portion 444 can be coupled such that at least a portion of the second portion 444 can be advanced relative to the first portion 442 towards a distal end of the first portion 442. For example, the first portion 442 can be coupled to the second portion 444 via any suitable coupling mechanism, such as, for example, a flexible circumferential portion. To release liquid within the reservoir 450 such that the liquid flows to the applicator pad 410, the second portion 444 can be advanced distally relative to the first portion 442 (e.g., via pressing on a proximal end of the second portion 444) such that the second release mechanism portion 464 applies a force to the proximal end of the reservoir 450 to urge the reservoir 450 distally such that contact between the neck portion 452 of the reservoir 450 and the ramp 462 causes the neck portion 452 to separate (e.g., break) from a remainder of the reservoir 450 and allow liquid to flow from the reservoir 450, out of the distal end of the first portion 442, and to the applicator pad 410, resulting in the applicator pad 410 being wetted with the liquid from the reservoir 450.
In some embodiments, the first portion 442 can include a filter to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 410. Before or after wetting the applicator pad 410 with the liquid, the distal surface of the applicator pad 410 can be disposed against a wound of the subject. The grip 440 can then be maintained against the applicator pad 410 such that the plate 431 applies distributed pressure to the applicator pad 410 for a period time, as described with respect to the method 200 above. In some embodiments, the first portion 442 and/or the second portion 444 can be deformable (e.g., squeezable) to urge fluid (e.g., medication) from the reservoir 450. In some embodiments, the bleeding treatment system 400 can be operated with one hand (e.g., the hand of the subject having the wound in need of treatment). For example, the user can place a thumb on the proximal end of the second portion 444 and wrap the remaining fingers of the same hand around the sidewall of the grip 440 (e.g., around the first portion 442), with at least some of the remaining fingers in contact with the grip features 445. While gripping the grip 440 in this configuration, either before or after pressing the applicator pad 410 against the wound, the user can press the second portion 444 toward the applicator pad 410 with the user's thumb to release liquid from the reservoir 450 as described above.
The first portion 542 can include a plate 531 having a distal or bottom surface extending laterally relative to the central axis D of the grip 540. The applicator pad 510 can be disposed on a distal end of the first portion 542 (e.g., coupled to the distal surface of the plate 531). The first portion 542 can include a ramp portion 562 (also referred to as a first release mechanism portion) extending partially into the interior space 543 of the first portion 542 such that the neck portion 552 can contact the ramp portion 562. The first portion 542 can also include one or more retaining portions 547 (e.g., flexible tab or bump portions) extending toward the central axis A of the first portion 542 and configured to contact a shoulder of the body portion 554 of the reservoir 550 as shown in
The second portion 544 can include a projection 564 (also referred to as a second release mechanism portion) extending into the interior space 543. The first portion 542 and the second portion 544 can be coupled such that at least a portion of the second portion 544 can be advanced relative to the first portion 542 towards a distal end of the first portion 542. For example, the second portion 544 can include a slidable engagement portion 544A and the first portion 542 can include a receiving portion 544B having a corresponding shape and a larger perimeter than the outer diameter of the slidable engagement portion 544A such that the slidable engagement portion 544A can be translated into the receiving portion 544B (e.g., via pressing on a proximal end of the second portion 544 and/or gripping opposing sidewalls of the second portion 544 and advancing the second portion 544 distally). During the translation of the slidable engagement portion 544A into the receiving portion 544B, the second release mechanism portion 564 can apply a force to the proximal end of the reservoir 550 to urge the reservoir 550 distally such that contact between the neck portion 552 of the reservoir 550 and the ramp 562 causes the neck portion 552 to separate (e.g., break) from a remainder of the reservoir 550 and allow liquid to flow from the reservoir 550, out of the distal end of the first portion 542, and to the applicator pad 510, resulting in the applicator pad 510 being wetted with the liquid from the reservoir 550.
In some embodiments, the first portion 542 can include a filter (e.g., disposed between the ramp 562 and the distal opening of the grip 540) to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 510. Before or after wetting the applicator pad 510 with the liquid, the distal surface of the applicator pad 510 can be disposed against a wound of the subject. The grip 540 can then be maintained against the applicator pad 510 such that the plate 531 applies distributed pressure to the applicator pad 510 for a period time, as described with respect to the method 200 above. In some embodiments, the bleeding treatment system 500 can be operated with one hand (e.g., the hand of the subject having the wound in need of treatment). For example, the user can place a thumb on the proximal end of the second portion 544 and wrap the remaining fingers of the same hand around the sidewall of the grip 540 (e.g., around the first portion 542), with at least some of the remaining fingers in contact with the grip features 545. While gripping the grip 540 in this configuration, either before or after pressing the applicator pad 510 against the wound, the user can press the second portion 544 toward the applicator pad 510 with the user's thumb to release liquid from the reservoir 550 as described above.
To use the bleeding treatment system 600 to treat a wound and cease bleeding of the wound, the reservoir 650 can be inserted into the interior space 643 of the first portion 642. The second portion 644 can be coupled to a proximal end of the first portion 642. The cover 620 can be removed from the applicator pad 610. The second portion 644 can then be advanced distally in the direction of arrow A to apply pressure to the reservoir 650. Using any suitable reservoir and release mechanism structure, such as any of the reservoir and release mechanism structures described herein, liquid can be released from the reservoir 650 and flow to the applicator pad 610 such that medication M is disposed on the applicator pad 610.
The first portion 742 can include a plate 731 having a distal or bottom surface extending laterally relative to the central axis B of the grip 740. The applicator pad 710 can be disposed on a distal end of the first portion 742 (e.g., coupled to the distal surface of the plate 431). The first portion 742 can also include one or more retaining portions (not shown) (e.g., flexible tab or bump portions) extending toward the central axis B of the first portion 742 and configured to contact a shoulder of the body portion 754 of the reservoir 750 to retain the reservoir 750 in a proximal position. In some embodiments, rather than or in addition to including one or more retaining portion that contact the shoulder of the body portion 754, the first portion 742 can include retaining portions such as adhesive and/or an inner sidewall in frictional contact with the body portion 754 to retain the body portion 754 in a position in which the neck portion 752 is radially aligned with the second portion 744.
The second portion 744 can be formed as a deformable sidewall portion disposed in an opening defined by the first portion 742. The second portion 744 can optionally include a projecting portion 762 (also referred to as a release mechanism portion) extending and/or deformable laterally toward the central axis B and toward the neck portion 752 of the reservoir 750 in an initial configuration. The second portion 744 can be deformed via being pressed in by a finger of a user such that the projecting portion 762 is urged into sufficient contact with the neck portion 752 to break the neck portion 752 and release the liquid within the reservoir 750. In some embodiments, the second portion 744 can be sufficiently deformable that the second portion 744 can be urged into sufficient contact with the neck portion 752 to break the neck portion 752 such that the second portion 744 operates as the release mechanism portion without including the projecting portion 762. In some embodiments, the second portion 744 can be formed, for example, of silicone or a similar elastomeric material. Although not shown, in some embodiments, the grip 740 can include a ramp portion that can be the same or similar in structure and/or function to ramp portion 562. The ramp portion can be disposed relative to the neck portion 552 and the second portion 744 such that the second portion 744 can be deformed to urge the neck portion 552 into the ramp portion such that the neck portion 552 breaks relative to the body portion 554.
As shown in
To release liquid within the reservoir 750 such that the liquid flows to the applicator pad 710, the second portion 744 can be deformed laterally relative to the neck portion 752 (e.g., via pressing on the second portion 744 with a finger of the user such as a thumb) such that the contact between the second portion 744 and the neck portion 752 of the reservoir 750 causes the neck portion 752 to separate (e.g., break) from the body 754 of the reservoir 750 and allows liquid to flow from the reservoir 750, out of the distal end of the first portion 742, and to the applicator pad 710, resulting in the applicator pad 410 being wetted with the liquid from the reservoir 750.
The second portion 744 can include one or more grip features 745 on an exterior surface of the second portion 744 to improve the grip of the user during handling of the grip 740. The grip features 745 can include any suitable surface feature to increase grip or friction, such as one or more ridges (as shown in
In some embodiments, the first portion 742 can include a filter to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 710. Before or after wetting the applicator pad 710 with the liquid, the distal surface of the applicator pad 710 can be disposed against a wound of the subject. The grip 740 can then be maintained against the applicator pad 710 such that the plate 731 applies distributed pressure to the applicator pad 710 for a period time, as described with respect to the method 200 above. In some embodiments, the first portion 742 and/or the second portion 744 can be deformable (e.g., squeezable) to urge the medication from the reservoir 750 (e.g., after the neck portion 752 has been separated from the body portion 750). In some embodiments, the bleeding treatment system 700 can be operated with one hand (e.g., the hand of the subject having the wound in need of treatment). For example, the user can place a thumb on the second portion 744 and wrap the remaining fingers of the same hand around the sidewall of the grip 740 (e.g., around the first portion 742). While gripping the grip 740 in this configuration, either before or after pressing the applicator pad 710 against the wound, the user can press the second portion 744 toward the neck portion 752 with the user's thumb to release liquid from the reservoir 750 as described above.
The first portion 842 can include a plate 831 having a distal or bottom surface extending laterally relative to the central axis C of the grip 840. The applicator pad 810 can be disposed on a distal end of the first portion 842 (e.g., coupled to the distal surface of the plate 831). The first portion 842 can include a ramp portion 862 (also referred to as a first release mechanism portion) extending partially into the interior space 843 of the first portion 842 such that the neck portion 852 can contact the ramp portion 862. The first portion 842 can also include one or more retaining portions (not shown) (e.g., flexible tab or bump portions) extending toward the central axis C of the first portion 842 and configured to contact a shoulder of the body portion 854 of the reservoir 850 as shown in
The second portion 844 can include a distally-facing inner surface 864 (also referred to as a second release mechanism portion). The first portion 842 and the second portion 844 can be coupled such that the second portion 844 can be advanced relative to the first portion 842 towards a distal end of the first portion 842. For example, the first portion 842 can be coupled to the second portion 844 via any suitable coupling mechanism, such as, for example, threads or a slidable friction fit. The second portion 844 can have a larger inner diameter than an outer diameter of the proximal end of the first portion 842 such that the second portion 844 can be disposed in contact with an outer surface of the first portion 842. The reservoir 850 can be disposed in an initial position within the interior space 843 such that the proximal end of the reservoir is near or adjacent to the distally-facing inner surface 864 and can be advanced distally due to the second portion 844 being displaced distally. To release liquid within the reservoir 850 such that the liquid flows to the applicator pad 810, the second portion 844 can be advanced distally relative to the first portion 842 (e.g., via pressing on a proximal end of the second portion 844) such that the inner surface 864 applies a force to the proximal end of the reservoir 850 to urge the reservoir 850 distally such that contact between the neck portion 852 of the reservoir 850 and the ramp 862 causes the neck portion 852 to separate (e.g., break) from a remainder of the reservoir 850 (e.g., the body 854) and allows liquid to flow from the reservoir 850, out of the distal end of the first portion 842, and to the applicator pad 810, resulting in the applicator pad 810 being wetted with the liquid from the reservoir 850.
In some embodiments, the first portion 842 can include a filter to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 810. Before or after wetting the applicator pad 810 with the liquid, the distal surface of the applicator pad 810 can be disposed against a wound of the subject. The grip 840 can then be maintained against the applicator pad 810 such that the plate 831 applies distributed pressure to the applicator pad 810 for a period time, as described with respect to the method 200 above. In some embodiments, the first portion 842 and/or the second portion 844 can be deformable (e.g., squeezable) to urge the medication from the reservoir 850. In some embodiments, the bleeding treatment system 800 can be operated with one hand (e.g., the hand of the subject having the wound in need of treatment). For example, the user can place a thumb on the proximal end of the second portion 844 and wrap the remaining fingers of the same hand around the sidewall of the grip 840 (e.g., around the first portion 842). While gripping the grip 840 in this configuration, either before or after pressing the applicator pad 810 against the wound, the user can press the second portion 844 toward the applicator pad 810 with the user's thumb to release liquid from the reservoir 850 as described above.
The first portion 942 can include a plate 931 having a distal or bottom surface extending laterally relative to the central axis D of the grip 940. The applicator pad 910 can be disposed on a distal end of the first portion 942 (e.g., coupled to the distal surface of the plate 931). The first portion 942 can include a ramp portion 962 (also referred to as a first release mechanism portion) extending partially into the interior space 943 of the first portion 942 such that the neck portion 952 can contact the ramp portion 962. The first portion 942 can also include one or more retaining portions (not shown) (e.g., flexible tab or bump portions) extending toward the central axis D of the first portion 942 and configured to contact a shoulder of the body portion 954 of the reservoir 950 to retain the reservoir 950 in an initial proximal position until sufficient force is applied to a proximal end of the reservoir 950 to advance the reservoir 950 relative to the one or more retaining portions. The first portion 942 can also include one or more grip features (not shown) on an exterior surface of a sidewall of the first portion 942 to improve the grip of the user during handling of the grip 940. The grip features can include any suitable surface feature to increase grip or friction, such as one or more ridges, concave and/or convex curvatures, and/or a textured or course surface.
The grip can include a spring portion 946. The first portion 942 and the second portion 944 can be coupled such that the second portion 944 can be advanced relative to the first portion 942 towards a distal end of the first portion 942. For example, the first portion 942 can be coupled to the second portion 944 via any suitable coupling mechanism, such as, for example, threads or a slidable friction fit. The second portion 944 can have a larger inner diameter than an outer diameter of the proximal end of the first portion 942 such that the second portion 944 can be disposed in contact with an outer surface of the first portion 942. The reservoir 950 can be disposed in an initial position within the interior space 943 such that the proximal end of the reservoir is near or adjacent the distally-facing inner surface 964 and can be advanced distally due to the second portion 944 being displaced distally. In some embodiments, the spring portion 946 can be configured to transition from an initial configuration to an expanded or compressed configuration to bring the reservoir 950 into contact with the ramp 962. For example, the spring portion 946 can be activatable to urge the ramp 962 away from the applicator pad 910 and into breaking contact with the neck portion 952. In some embodiments, the spring portion 946 may be activatable to pull or push the reservoir 950 into contact with the ramp 962. The second portion 944 can be engaged with the spring portion 946 such that depression or twisting of the second portion 944 causes the spring portion 946 to activate. Thus, to release liquid within the reservoir 950 such that the liquid flows to the applicator pad 910, the second portion 944 can be twisted or advanced distally relative to the first portion 942 (e.g., via rotating or pressing on a proximal end of the second portion 944) such that the spring portion 946 is released from an initial configuration. The spring portion 946 can then translate the reservoir 950 and/or the ramp 962 such that contact between the neck portion 952 of the reservoir 950 and the ramp 962 causes the neck portion 952 to separate (e.g., break) from a remainder of the reservoir 950 (e.g., the body 954) and allows liquid to flow from the reservoir 950, out of the distal end of the first portion 942, and to the applicator pad 910, resulting in the applicator pad 910 being wetted with the liquid from the reservoir 950.
In some embodiments, the first portion 942 can include a filter to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 910. Before or after wetting the applicator pad 910 with the liquid, the distal surface of the applicator pad 910 can be disposed against a wound of the subject. The grip 940 can then be maintained against the applicator pad 910 such that the plate 931 applies distributed pressure to the applicator pad 910 for a period time, as described with respect to the method 200 above. In some embodiments, the first portion 942 and/or the second portion 944 can be deformable (e.g., squeezable) to urge the medication from the reservoir 950. In some embodiments, the bleeding treatment system 900 can be operated with one hand (e.g., the hand of the subject having the wound in need of treatment). For example, the user can place a thumb on the proximal end of the second portion 944 and wrap the remaining fingers of the same hand around the sidewall of the grip 940 (e.g., around the first portion 942). While gripping the grip 940 in this configuration, either before or after pressing the applicator pad 910 against the wound, the user can press the second portion 944 toward the applicator pad 910 with the user's thumb to release liquid from the reservoir 950 as described above.
In some embodiments, rather than including a reservoir within a grip of an applicator device, an applicator pad, such as any of the applicator pads described herein, can be prefilled with medication. For example,
In step 1204, whether the subject (e.g., a patient) is on a medication (e.g., an anticoagulant drug or antiplatelet drug) that predisposes the subject to increased and/or prolonged bleeding can be determined. For example, a caregiver or clinician can check to see if such a medication has been taken by the subject within a relevant time period (e.g., by checking a medical record or asking the subject). In some embodiments, step 1204 can be not included and a user can proceed directly to step 1206 described below. In some embodiments, step 1204 can be performed after step 1206 if the wound is still bleeding, and the steps of the method 1200 can proceed from there.
In step 1206, if the subject is determined not to have taken a medication that predisposes the subject to increased and/or prolonged bleeding within a relevant time period, the firm pressure can be applied to the wound using a sterile gauze pad (e.g., by the subject or a caregiver). In some embodiments, the firm pressure can be applied for a first period of time (e.g., a predetermined period of time). In some embodiments, for example, the first period of time can be about five minutes, between about four minutes and about six minutes, less than about four minutes, greater than about five minutes, greater than about six minutes. After the first period of time, the pressure can be removed. If the wound is no longer bleeding, the subject or a caregiver can apply a bandage to the wound. If the wound is still bleeding, then step 1208 can be performed as described below and/or medical attention may be sought.
In step 1208, if the subject is determined to have taken a medication that predisposes the subject to increased and/or prolonged bleeding within a relevant time period, or if applying firm pressure for the first period of time as described in step 1206 has not caused bleeding to stop, firm pressure can be applied to the wound using a topical applicator pad containing a metered dose of medication (e.g., TXA such as intravenous (IV) TXA) for a second period of time (e.g., a second predetermined period of time) (e.g., five minutes) such that the medication contacts the wound. In some embodiments, the second period of time can be greater than the first period of time. In some embodiments, the second period of time can be less than the first period of time. In some embodiments, the metered dose can be between three and ten mL and/or include between about 300 and about 1000 mg of medication.
In step 1210, the pressure can be removed by the subject or a caregiver (e.g., via removing the applicator pad) and the wound can be checked to see if the wound is still bleeding. In step 1212, if the wound is no longer bleeding, a bandage can be applied to the wound by the subject or a caregiver. In step 1214, if the wound is still bleeding, the subject or a caregiver can reapply firm pressure to the wound using the topical applicator pad for an additional predetermined time period (e.g., for an additional five minutes). In some embodiments, a new topical applicator pad (containing a metered dose or not containing a metered dose of medication) may be used. In step 1216, the pressure can be removed and checked to see if the wound is still bleeding. In step 1218, if the wound is no longer bleeding, a bandage can be applied to the wound if needed. In step 1220, if the wound is still bleeding, the subject can seek medical attention (with the help of a caregiver if needed).
In some embodiments, the applicator pad 1310 can be coupled to the applicator device 1370 via adhesive strips 1303 that are releasable from the applicator device 1370 via, for example, the pad connector 1348 which can operate as a release mechanism to allow the adhesive strips 1303 to contact skin of a patient to secure the pad connector 1348 to a wound WD. Thus, in the first configuration shown in
As shown in
The system 1400 can be placed on a surface of a subject with the applicator pad 1410 and the bandage 1412 in contact with the surface, the applicator pad 1410 contacting a wound of the subject and the bandage 1412 surrounding the applicator pad 1410. The applicator device 1470 can be transitioned from an initial configuration to the wetting configuration shown in
In some embodiments, the applicator pad 1410 and the bandage 1412 can be left on the skin of the subject such that the applicator pad 1410 remains in contact with the wound, and the grip 1440 can be decoupled from the applicator pad 1410 and the bandage 1412 such that the applicator pad 1410 is not displaced relative to the wound during the decoupling. As shown in
The grip 1440 can be coupled to and/or decoupled from the applicator pad 1410 and/or the bandage 1412 via any suitable decoupling method described herein. For example, as shown in
In some embodiments, as shown in
In some embodiments, an applicator pad can include or be coupled to a rigid or semi-rigid backing portion that is configured to be releasably engaged by a portion of an applicator device. For example,
As shown in
As shown in
The backing portion 1718 and/or the applicator pad 1710 can include or be coupled to a pad retainer portion 1735B extending away from the applicator pad 1710 and configured to be releasably grasped by a pad retainer portion 1735A of the grip 1740. The pad retainer portion 1735A of the grip 1740 can include, for example, flexible arms configured to engage with a recess of the pad retainer portion 1735B such that the grip 1740 and the applicator pad 1710 are coupled (e.g., during wetting and/or applying pressure to the wound). To separate the grip 1740 from the applicator pad 1710, the flexible arms can be pulled away from the recess of the pad retainer portion 1735B (e.g., via pulling on tabs extending from an outer surface of the grip 1740 or by squeezing engagement mechanisms (e.g., semicircular buttons) near or adjacent to the distal end of the grip 1740 to activate a release mechanism such that the pad retainer portion 1735B is released) and the grip 1740 can be removed from the pad retainer portion 1735B.
In some embodiments, the contents of a reservoir can be configured to flow from the reservoir to an applicator pad through a sidewall of a grip containing the reservoir. For example,
The grip 1940 can include a first portion 1942 and a second portion 1944 collectively defining the interior space within which the reservoir 1950 is disposed. The first portion 1942 can be configured to be bent relative to the second portion 1944 as shown in
After the reservoir 1950 is broken, the contents of the reservoir 1950 can flow from the reservoir 1950 to the applicator pad 1910 through a sidewall of the grip 1940. For example, the grip 1940 can define one or more openings through which fluid can flow to the applicator pad 1910, which may be coupled or releasably coupled to a sidewall of the grip 1940 and aligned with the openings. In some embodiments, the grip 1940 can include a filter (not shown) disposed between the reservoir 1950 and the applicator pad 1910 to prevent unwanted material (e.g., particles above a certain size and/or glass pieces) from reaching the applicator pad 1910. For example, the filter can be disposed within or adjacent to the one or more openings defined by the grip 1940.
In some embodiments, the grip 1940 can be releasably coupled to the applicator pad 1910 using any of the releasable coupling mechanism described herein such that, as shown in
In some embodiments, a force concentrating component can be disposed on a first portion or a second portion of a grip and the second portion of the grip can be moved (e.g., rotated and/or translated) relative to a first portion of the grip containing a reservoir to break the reservoir due to contact between the reservoir and the force concentrating component. For example,
In some embodiments, an applicator pad can be prepared (e.g., wetted) in a tray included in a kit prior to being applied to a target wound or treatment area of a subject. For example,
In some embodiments, an applicator device such as any of the applicator devices described herein can be included in the kit 2100 can used to release the contents of the reservoir. The applicator device can then be used to apply the applicator pad 2110 to the wound and to apply pressure to the wound, or the applicator pad 2110 can optionally be separated from the applicator device (e.g., in the tray 2101) and the applicator pad 2110 can be applied to the wound and pressed against the wound using fingers and/or a palm of the subject or caregiver. Optionally, the backing portion 2118 can be applied to the applicator pad 2110 before or after applying the applicator pad 2110 to the wound.
As shown in
In some embodiments, an applicator device such as any of the applicator devices described herein can be included in the kit 2200 can used to release the contents of the reservoir. The applicator device can then be used to apply the applicator pad 2210 to the wound and to apply pressure to the wound, or the applicator pad 2210 can optionally be separated from the applicator device (e.g., in the tray 2201) and the applicator pad 2210 can be applied to the wound and pressed against the wound using fingers and/or a palm of the subject or caregiver. Optionally, the backing portion 2218 can be applied to the applicator pad 2210 before or after applying the applicator pad 2210 to the wound.
In some embodiments, the reservoir 2350 can be configured such that liquid (e.g., medication such as TXA and/or activating liquid such as saline) within the reservoir 2350 can be displaced and/or pressurized to initiate flow of the liquid from the reservoir 2350 to the applicator pad 2310. For example, the reservoir 2350 can be closed on a distal end by the release mechanism 2360 that may be the same or similar in structure and/or function to any of the release mechanisms described herein. The release mechanism 2360 can be formed as a pierceable or breakable membrane, such as a rubber membrane (e.g., a resealable membrane) or a frangible membrane such as film or foil, that can be pierced by the piercing member 2399 to allow fluid to flow from the reservoir 2350. The reservoir 2350 can be configured to be moved (e.g., translated) into piercing contact with the piercing member 2399 such that fluid can be released and/or urged from the reservoir 2350. The reservoir 2350 can include a rigid housing at least partially defining an interior space within which the liquid is disposed. In some embodiments, the reservoir 2350 can be formed as a cartridge including a housing having a distal open end closed by a pierceable release mechanism 2360 (e.g., a cap, lined cap, or cover) in an initial configuration and a proximal open end closed by a movable piston or plunger. In some embodiments, the reservoir 2350 can be formed as a vial including a housing having a distal open end closed by a pierceable release mechanism 2360 (e.g., a cap, lined cap, or cover) in an initial configuration and a closed proximal end. In some embodiments, the reservoir 2350 can be formed as a syringe including a housing having a distal open end closed by a pierceable release mechanism 2360 (e.g., a cap, lined cap, or cover) in an initial configuration and a proximal end configured to receive a plunger therethrough such that a distal piston-end of the plunger is translatable within the housing and creates a fluidic seal with inner sidewalls of the housing to prevent liquid within an interior of the housing from flowing proximally beyond the piston-end of the plunger. In some embodiments, the reservoir 2350 (e.g., formed as a vial) can be preloaded with compressed gas (e.g., compressed argon gas) in addition to the liquid such that piercing or otherwise breaking the release mechanism 2360 results in the liquid being automatically urged from the reservoir 2350 under the force of the expanding gas. In some embodiments, the reservoir 2350 can be shaped and sized to hold and dispense 10 ml of fluid. In some embodiments, the reservoir 2350 can be shaped and sized to hold and dispense any suitable volume of fluid in an initial configuration, such as, for example, 3 ml of fluid, 5 ml of fluid, 7 ml of fluid, or 7.5 ml of fluid.
In some embodiments, the applicator device 2370 in combination with the reservoir 2350, or any of the applicator devices in combination with any of the reservoirs described herein, can be configured to contain liquid. In some embodiments, the applicator device 2370 in combination with the reservoir 2350, or any of the applicator devices in combination with any of the reservoirs described herein, can be configured to contain any suitable substance, such as any suitable flowable substance or any suitable higher viscosity substance (e.g., medication). For example, the applicator device 2370 in combination with the reservoir 2350, or any of the applicator devices in combination with any of the reservoirs described herein, can be configured to contain an ointment, a cream, a liniment, a paste, a lotion, a gel, a hydrogel, a liposome, a spray, an aerosol, a solution, a salve, or a higher viscosity medication, such as any substance described herein.
In some embodiments, rather than including a piercing member 2499, the release mechanism 2360 can be configured to burst as a result of a pressure of the liquid within the reservoir increasing above a threshold pressure. For example, the release mechanism 2360 can include a pressure seal, a silicone flapper seal, or a breakable adhesive. The liquid could then flow to the applicator pad 2310 via an opening in a distal end of the first portion 2342 and/or via the fluid coupling 2355.
The activation mechanism 2398 can include any suitable activation mechanism 2398 configured to urge the reservoir 2350 and/or the liquid within the reservoir 2350 (e.g., via an interaction with a piston and/or plunger of the reservoir 2350) toward the applicator pad 2310. In some embodiments, the activation mechanism 2398 can include a spring, a plunger configured to move a piston of the reservoir 2350, a plunger assembly configured to push air into the reservoir 2350 to displace liquid from the reservoir 2350, compressed gas pre-loaded into the reservoir 2350 with the liquid as described above, an activation reservoir configured to expand in response to a chemical reaction to propel the reservoir 2350 and/or liquid within the reservoir 2350 distally, and/or any other suitable activation mechanism.
The second portion 2344 of the grip 2340 can be formed as any suitable component configured to be manipulated (e.g., by a self-administering home user, a caregiver, or a patient) to release and/or cause movement of the activation mechanism 2398. For example, the second portion 2344 can be formed as a retaining pin configured to be engaged with the first portion 2342, the reservoir 2350, and/or the activation mechanism 2398 to prevent expansion of a spring of an activation mechanism 2398 from an initial configuration to an expanded configuration. In some embodiments, the retaining pin can be configured to be disengaged or decoupled from the spring (e.g., via being decoupled from a retaining member coupled to a distal end of the spring and/or from a piston of the reservoir 1250) such that the spring can expand to apply pressure to the reservoir 2350 (e.g., to urge the reservoir 2350 distally such that the release mechanism 2360 is pierced by the piercing member 2399 and/or to urge a piston and/or plunger of the reservoir 2350 distally to push liquid from the reservoir 2350). In some embodiments, the second portion 2344 can be formed as a plunger advanceable by a user relative to the first portion 2342 (e.g., while in contact with the reservoir 2350 to advance the reservoir 2350 itself and/or a plunger of the reservoir 2350) to apply pressure to the reservoir 2350. In some embodiments, the second portion 2344 can include threads configured to mate with threads of the first portion 2342 and can be configured to be rotated relative to the first portion 2342 such that the second portion 2344 is moved distally and applies pressure to the reservoir 2350 to urge the reservoir 2350 distally and/or to urge a piston and/or plunger of the reservoir 2350 distally to push liquid from the reservoir 2350. In some embodiments, the second portion 2344 can be formed as a distal housing portion configured to receive the applicator pad 2310 within an open distal end and configured to be translated relative to the first portion 2342 (e.g., into an interior of the first portion 2342) by applying a force to the first portion 2342 that is in the direction of a wound in contact with the applicator pad 2310.
In some embodiments, the fluid coupling 2355 can be a portion of the interior space 2343 defined by the housing of the first portion 2342 via which liquid can flow from the reservoir 2350 to the applicator pad 2310. In some embodiments, the fluid coupling 2355 includes a separate tubular member defining a lumen through which liquid can flow from the reservoir 2350 to the applicator pad 2310. In some embodiments, the fluid coupling 2355 can be a distal opening formed in the grip 2340. In some embodiments, the fluid coupling 2355 can be formed as a tubular portion coupled to the applicator pad 2310 configured to be coupled to the grip 2340 and/or a portion of the reservoir 2350 projecting distally from the grip 2340. For example, the fluid coupling 2355 can include a connector such as a Luer connector or a friction fit connector configured to be coupled to the grip 2340 and/or the reservoir 2350 such that fluid flowing from the reservoir 2350 can travel to the applicator pad 2310 through the fluid coupling 2355. After liquid transfer, the fluid coupling 2355 can be decoupled from the grip 2340 and/or the reservoir 2350, leaving the applicator pad 2310 in place (e.g., on a surface of a patient). In some embodiments, the fluid coupling 2355 can be a lumen defined by the piercing member 2399 (e.g., the piercing member 2399 can be a hollow needle).
In some embodiments, the piercing member 2399 can be disposed at a distal end of the grip 2340 (coupled to or included in the first portion 2342) and can project into the interior space 2343 toward the reservoir 2350. In some embodiments, the piercing member 2399 can be coupled to the applicator pad 2310 (e.g., disposed within the fluid coupling 2355 or within or adjacent another fluid coupling or connector), which may be couplable to and/or separable from the grip 2340. In some embodiments, the piercing member 2399 can be coupled to the second portion 2344. In some embodiments, the piercing member 2399 can include one or more lumens configured to allow the flow of liquid from the reservoir 2350 to the applicator pad 2310. In some embodiments, the piercing member 2399 or an additional piercing member can include one or more lumens configured to allow the flow of fluid (e.g., gaseous fluid) into the reservoir 2350 to displace liquid from the reservoir 2350. In some embodiments, the piercing member 2399 does not define a lumen. In some embodiments, the activation mechanism 2398 is configured to urge the release mechanism 2360 of the reservoir 2350 toward the piercing member 2399 such that the piercing member 2399 penetrates the release mechanism 2360 to initiate transfer of liquid from the reservoir 2350. In some embodiments, the first portion 2342 is configured to be translated distally relative to the piercing member 2399 and the reservoir 2350 can be in a fixed location relative to the first portion 2342 such that the release mechanism 2360 is translated into piercing contact with the piercing member 2399 to initiate transfer of liquid from the reservoir 2350 and the activation mechanism 2398 is configured to urge a portion of the reservoir 2350 (e.g., a piston) toward the piercing member 2399 to urge fluid from the reservoir 2350. The piercing member 2399 can be formed of any suitable material, such as metal or plastic.
In some embodiments, the grip 2340 is arranged relative to the applicator pad 2310 such that a central axis of the grip 2340 (or of the first portion 2342 of the grip 2340) is perpendicular to the wound-facing surface of the applicator pad 2310 (e.g., when the applicator pad 2310 is in contact with the wound). In some embodiments, the grip 2340 is arranged relative to the applicator pad 2310 such that a central axis of the grip 2340 (or of the first portion 2342 of the grip 2340) is disposed at an angle (e.g., a 45 degree angle) to the wound-facing surface of the applicator pad 2310 (e.g., when the applicator pad 2310 is in contact with the wound).
In some embodiments, rather than including one reservoir 2350 and one piercing member 2399, the system 2300 can include any suitable number of reservoirs and piercing members. For example, the system 2300 can include two reservoirs 2350 and two piercing members 2399, three reservoirs 2350 and three piercing members 2399, four reservoirs 2350 and four piercing members 2399, etc. In some embodiments, the system 2300 can include an activation mechanism 2398 (e.g., a spring) associated with each reservoir 2350, and a single second portion 2344 configured to simultaneously activate each of the activation mechanisms 2398. In some embodiments, the system 2300 includes one common activation mechanism 2398 configured to be activated by the second portion 2344.
The first portion 2342 can be formed in any suitable shape. For example, the first portion 2342 can include a cylindrical or tubular housing. In some embodiments, the first portion 2342 can include or be coupled to a plate 2341 disposed at the distal end of the first portion 2342 and configured to apply pressure to the applicator pad 2310 and thus a target wound. In some embodiments, the plate 2341 may form a bottom surface of the grip 2340. In some embodiments, the plate 2341 may be formed as a flange (e.g., a circumferential flange) extending from a bottom edge of the first portion 2342. In some embodiments, the plate 2341 can be separable from the grip 2340 (e.g., via decoupling the fluid coupling 2355 when the fluid coupling 2355 is coupled to the applicator pad 2310 or via decoupling the plate 2341 from the first portion 2342).
In some embodiments, the grip 2340 and/or applicator pad 2310 includes an applicator seal 2320 configured to cover at least the distal or skin-contacting surface of the applicator pad 2310 to prevent contamination of the applicator pad 2310 and, optionally, leakage from or drying of the applicator pad 2310 prior to use. The applicator seal 2320 can be formed, for example, as a film (e.g., a peelable film). In some embodiments, the applicator seal 2320 can be formed of a shrink wrap material covering the distal end of the applicator pad 2310 and positioned over at least a portion of the length of the first portion 2342.
The applicator pad 2310 can be the same or similar in structure and/or function to any of the applicator pads described herein. For example, the applicator pad 2310 can include and/or be coupled to an optional blood absorption pad 2330 and/or an optional pad retainer 2335. The blood absorption pad 2330 and the pad retainer 2335 can be the same or similar in structure and/or function to any of the blood absorption pads or pad retainers, respectively, described herein. In some embodiments, the applicator pad 2310 can have a cylindrical or conical shape.
In some embodiments, the applicator pad 2310 can be coupled to a backing portion (e.g., a bandage or a flexible or rigid cup) (e.g., via adhesive). The backing portion can be the same or similar in structure and/or function to any of the backing portions described herein, and can be configured to be coupled to the applicator pad 2310 to apply increased pressure to the wound via the applicator pad 2310 and to retain the applicator pad 2310 in place relative to the wound. The applicator pad 2310 can then be disposed in contact with the wound with the backing portion being coupled to the skin surrounding the wound. In some embodiments, the backing portion can be removed after a predetermined period of time (e.g., four, five, six, or ten minutes, 8 hours). In some embodiments, the backing portion can be applied to the applicator pad 2310 before or after applying the applicator pad 2310 to the wound. In some embodiments, the backing portion is coupled to the applicator pad 2310 before the applicator pad 2310 is wetted with the liquid from the reservoir 2350. Thus, in some embodiments, the backing portion can extend laterally from the grip 2340 or be folded upward against an outer surface of the grip 2340 when the applicator pad 2310 is coupled to the grip 2340 to receive the liquid form the reservoir 2350. In some embodiments, the backing portion can be graspable by a user and coupled to the applicator pad 2310 such that the applicator pad 2310 can be separated from the grip 2340 via pulling on the backing portion.
Prior to use, the applicator device 2370 can be disposed in an initial configuration. In some embodiments, in the initial configuration, the applicator pad 2310 can be coupled to the distal end of the grip 2340. The applicator seal 2320 can cover the applicator pad 2310. To use the applicator device 2370, the applicator seal 2320 can be optionally removed and the grip 2340 can be used to apply the applicator pad 2310 to a wound. To release the liquid from the reservoir 2350 such that the liquid flows to the applicator pad 2310, the second portion 2344 can be configured to be moved relative to the first portion 2342 (e.g., via translation relative to the first portion 2342, disengagement from the first portion 2342, and/or rotational movement relative to the first portion 2342) to engage or disengage with the reservoir 2350 and/or the release mechanism 2360.
The applicator pad 2310 can optionally be pressed against target wound tissue using the grip 2340. The applicator pad 2310 can optionally be maintained relative to the wound (e.g., without maintaining the grip 2340 against the applicator pad 2310) via coupling the applicator pad 2310 to the skin via the pad retainer 2335. The applicator pad 2310 can be optionally separated from the applicator pad 2310 via releasing the applicator pad 2310 from the grip 2340 (e.g., via releasing a pad connector 2348 optionally included in the applicator device 2370 which can be the same or similar in structure and/or function to any of the pad connectors described herein). In some embodiments, the applicator pad 2310 can be configured to separate from the first portion 2342 when saturated without manual intervention or without significant manual intervention (e.g., via expanding out of a recess the applicator pad 2310 is at least partially disposed within, due to an increased weight that causes the applicator pad 2310 to fall from a recess when wet, and/or due to the decreased friction between the applicator pad and the first portion 2342 when the applicator pad is saturated).
Similar to the embodiment of the bleeding treatment system 2300, the bleeding treatment system 2400 may include an applicator seal (not shown) (similar to the applicator seal 2320 of the bleeding treatment system 2300) configured to cover at least the distal or skin-contacting surface of the applicator pad 2410 to prevent contamination of the applicator pad 2410 and, optionally, leakage from or drying of the applicator pad 2410 prior to use. The applicator seal can be formed, for example, as a film (e.g., a peelable film) such as a shrink wrap material. The applicator pad 2410 can be the same or similar in structure and/or function to any of the applicator pads described herein.
The reservoir 2450 can be formed as a cartridge including a rigid housing defining an interior configured to be prefilled with a medication (e.g., liquid). The reservoir 2450 can have a distal open end closed by the release mechanism 2460 (e.g., a cap or cover) and a proximal open end closed by a movable piston 2451. The release mechanism 2460 can be the same or similar in structure and/or function to any of the release mechanisms described herein (e.g., the release mechanism 2360). In the initial configuration of the system 2400, the movable piston 2451 is located at a proximal end PE of the housing of the reservoir 2450, as shown in
The applicator device 2470 includes an activation mechanism 2498 configured as a spring and arranged to apply pressure to the piston 2451 to urge the piston 2451 distally. When the activation mechanism 2498 is released, the activation mechanism 2498 can transition from a compressed state to an expanded state. Initially, due to the liquid disposed within the reservoir 2450 being substantially incompressible, the expansion of the activation mechanism 2498 toward (e.g., against) the piston 2451 causes the entire reservoir 2450 to be urged towards the piercing member 2499 such that the piercing member 2499 pierces the release mechanism 2460 and releases liquid from the reservoir 2450. The liquid can flow from the reservoir 2450 to the applicator pad 2410 via the lumen of the piercing member 2499.
As shown in
The reservoir 2450 can be retained in a position in which the release mechanism 2460 is spaced from the piercing member 2499 by the engagement between the extension member 2444E and the through-hole 2452. Removal of the retaining pin 2444 from the through-hole 2452 and the opening 2453A allows for the reservoir 2450 to be translated distally by the activation mechanism 2498 such that the activation mechanism is thereby released. The activation mechanism 2498 can then push the reservoir 2450 into sufficient engagement with the piercing member 2499 such that the tip of the piercing member 2499 pierces the release mechanism 2460. Once the release mechanism 2460 is pierced, the activation mechanism 2498 can push the piston 2451 from the proximal end PE towards the distal end DE of the reservoir 2450, causing the delivery of the fluid from the reservoir 2450 via the lumen of the piercing member 2499.
In some embodiments, an inner diameter of the first portion 2442 in a distal region of the first portion 2442 (in which the housing of the reservoir 2450 is disposed in the initial configuration of the system 2400) can be larger than an inner diameter of the first portion 2442 in a proximal region of the first portion 2442 (in which the activation mechanism 2498 is disposed in the initial configuration of the system 2400) such that the piston 2451 and activation mechanism 2498 do not stick during expansion of the activation mechanism 2498. The piston 2451 can, in some embodiments, be partially disposed between the distal region and the proximal region of the first portion 2442. The distal region and the proximal region of the first portion 2442 can be separated, for example, by the first opening 2453A and the second opening. In some embodiments, the inner diameter of the housing of the cartridge can be the same or larger than the inner diameter of the proximal region of the first portion 2442.
In some implementations, rather than the retaining pin 2444 engaging with the piston 2451 to prevent release of the activation mechanism 2498 by preventing translation of the piston 2451, the retaining pin 2444 can be engaged directly with the activation mechanism 2498 or another component coupled to a distal end of the activation mechanism to prevent expansion of the activation mechanism 2498.
In the example implementation, the activation mechanism 2498 may be a coiled spring under compression, as shown, for example, in
As described above and shown in
To use the applicator device 2470, the optional applicator seal can be removed and the applicator device 2470 can be placed such that the applicator pad 2410 contacts a wound on a surface of a skin of the user. For example, if the user has a wound on one arm, the user can use one hand of the opposite arm to dispose the applicator device 2470 over the wound such that the applicator pad 2410 is in contact with the wound. The user can pull the retaining pin 2444 with a finger of the one hand (i.e., the hand that holds the applicator device 2470), thereby releasing the activation mechanism 2498 to initiate release of liquid from the reservoir 2450 to the absorbent pad 2410 and, thus, to the wound. The user can maintain pressure against the wound by holding the applicator device 2470 against the absorbent pad 2410 against the wound as described herein. Alternatively, the user can pull out the retaining pin 2444 prior to using the applicator device 2470, and, while the applicator pad 2410 is being saturated with the fluid from the reservoir 2450 or after the saturation operation is complete, the user can dispose the applicator pad 2410 against the wound and maintain the applicator device 2470 against the applicator pad 2410 to apply compression to the wound via the plate 2441 and the applicator pad 2410.
In some cases, as described above, the applicator pad 2410 saturated with the fluid from the fluid reservoir 2450 may be releasable from the first portion 2442 and may optionally be configured to remain coupled to the wound via being attached to skin surrounding the wound (via, for example, adhesive) for continued compression of the wound (e.g., via the user's hand against the applicator pad 2410 and/or compression applied by the applicator pad 2410 itself). Additionally, the applicator pad 2410 can be used to prevent contamination of the wound and for continued wound treatment with a medication. In some implementation, the applicator pad 2410 may be coupled to the first portion 2442 by means of a sticky adhesive layer, and may be detachable by separating (e.g., manually) the applicator pad 2410 from the first portion 2442 (e.g., after the applicator pad 2410 is coupled to the wound of the user). Alternatively, the applicator pad 2410 may be coupled to the first portion 2442 by means of a pad retainer, such as any of the pad retainers described herein. For example, the pad retainer may include one or more hooks, clamps, and the like. In some embodiments, the applicator pad 2310 may be disposed within the receptacle defined by the distal end portion 2442B via a compression or friction fit, and may expand and separate from the distal end portion 2442B upon being wet with the liquid from the reservoir 2450.
In some implementations, the applicator pad 2410 may not be decoupled from the first portion 2442 and may be configured to be held against the wound for a duration of time required for the wound treatment (e.g., the applicator pad 2410 may be held against the wound for a minute, a few minutes, ten minutes, a few tens of minutes, a few hours, and the like, for facilitating coagulation of blood in the wound). The applicator pad 2410 may be pressed against the wound by user pressing the applicator device 2470 towards the wound. The applicator pad may be left on the wound with an adhesive bandage for hours (e.g., up to 24 hours).
The applicator pads described herein, such as the applicator pad 2410, can be any suitable shape and size. For example,
The first portion 2542 and the second portion 2544 can be the same or similar in structure and/or function to the first portion 2442 and the second portion 2444 described above. For example, the second portion 2544 can be formed as a retaining pin 2544. The retaining pin 2544 can include an extension member 2544E and a handle portion 2544H. The first portion 2544 and the piston 2551 are configured to receive the extension member 2544E of the retaining pin 2544 in the initial configuration of the system such that the retaining pin 2544 retains the activation mechanism 2598 in the initial configuration and prevents movement of the activation mechanism 2598 and the piston 2551 relative to the first portion 2542. The first portion 2542 defines a first opening 2553A and a second opening 2553B on opposite sides of the housing 2542. Each of the first opening 2553A and the second opening 2553B are configured to receive the extension member 2544E of the retaining pin 2544 in the initial, retaining configuration. In some embodiments, the free end of the extension member 2544E can be visually identifiable within the second opening 2553B (e.g., by the user) to confirm that the extension member 2544E is properly engaged with the first portion 2542 and the piston 2551. Additionally, the piston 2551 defines a through-hole or socket 2552 configured to receive the extension member 2544E such that the piston 2551 can be retained in place relative to the openings 2553A, 2553B by the extension member 2544E. In some embodiments, the piston 2551 can include a piston portion 2551A and a retention portion 2551B coupled to a proximal end of the piston portion 2551, and the through-hole or socket 2552 can be defined between the piston portion 2551A and the retention portion 2551B. The piston 2551 (e.g., the retention portion 2551B) can include a flat proximal surface (as shown in
The reservoir 2550 can be retained in a position in which the release mechanism 2560 is spaced from the piercing member 2599 by the engagement between the extension member 2544E and the through-hole 2552. Removal of the retaining pin 2544 from the second opening 2443B, the through-hole 2552, and the first opening 2553A allows for the reservoir 2550 to be translated distally by the activation mechanism 2598 such that the activation mechanism is thereby released. The activation mechanism 2598 can then push the reservoir 2550 into sufficient engagement with the piercing member 2599 such that the tip of the piercing member 2599 pierces the release mechanism 2560. Once the release mechanism 2560 is pierced, the activation mechanism 2598 can push the piston 2551 from the proximal end PE towards the distal end DE of the reservoir 2550, causing the delivery of the fluid from the reservoir 2550 via the lumen of the piercing member 2599.
The activation mechanisms 2698a-2698c may be released at the same time when a user pulls out a retaining clip 2644 (the retaining clip 2644 is shown, for example, in
The applicator pad 2610 can be coupled to a backing portion 2618 that may be configured as a bandage. The backing portion 2618 can include an adhesive covered by a peel-away adhesive liner disposed on a distal surface of the backing portion 2618. The adhesive liner can be peeled away prior to placing the backing portion 2618 on a subject's skin so that the backing portion 2618 can be adhered to the skin via the adhesive. The backing portion 2618 may be similar or the same as any of the backing portion described herein.
In some embodiments, rather than the reservoir being formed as a cartridge, the reservoir can be formed as a vial. For example,
The applicator device 2770 includes a grip 2740 having a first portion 2742 and a second portion 2744 configured to move (e.g., translate) relative to the first portion 2742. As shown in
The applicator device 2770 also includes an activation mechanism 2798 (also referred to as an activation assembly) configured to initiate urging of liquid from the reservoir 2750. The activation mechanism 2708 includes a plunger 2771 and a barrel 2772 defining a gas reservoir. The gas reservoir of the barrel 2772 is fluidically coupled to the lumen 2799g of the pierceable member 2799 via a fluid coupling 2772a, which may include any suitable combination of fluid couplings such as tubular fluid connectors and may include any suitable filters or valves (e.g., one-way valves). The plunger is configured 2771 to be translated relative to the barrel 2772 to urge gas initially disposed within the barrel 2772 into the lumen 2799g via the fluid coupling 2772a. As shown in
In use, a user can apply pressure to the second portion 2744 to advance the second portion 2744 distally relative to the first portion 2742. Due to the reservoir 2750 being retained with in the cavity 2744c and the plunger 2771 being disposed within the cavity 2744d, as the second portion 2744 moves distally towards the piercing member 2799, both the plunger 2771 and the reservoir 2750 are also moved distally under the control of the second portion 2744. Once the release mechanism 2760 is pierced by the piercing member 2799 and the proximal or free end of the piercing member 2799 (including the proximal ends of the lumen 2799g and the lumen 2799f) is disposed within the interior of the reservoir 2750 (due to the second portion 2744 advancing the reservoir 2750 sufficiently far), further distal translation of the second portion 2744 causes the plunger 2771 to apply pressure to gas within the barrel 2772, thereby expelling at least some amount of the gas from the barrel 2772, through the fluid coupling 2772a, through the lumen 2799g of the piercing member 2799, and into the interior of the reservoir 2750. The gaseous fluid that travels into the interior of the reservoir 2750 can displace the liquid fluid in the reservoir 2750 to urge the liquid fluid through the lumen 2799f to the applicator pad 2710.
In some embodiments, the lengths of the plunger 2771, the barrel 2772, and the piercing member 2799 and the diameter of the barrel 2772 can each be selected to optimize liquid fluid transfer from the vial 2750 to the absorbent pad 2710. For example, the lengths and diameter may be selected such that the piercing member 2799 is sufficiently short to be able to receive liquid from a bottom portion of the vial 2750, while the barrel 2772 may have a sufficiently large diameter such that sufficient gas can be introduced to the vial 2750 to urge the liquid from the vial 2750 even at shorter barrel and/or plunger lengths. In some embodiments, the proximal end of the plunger 2798 can be spaced from the contacting wall of the cavity 2744d such that the second portion 2744 does not begin to translate the plunger 2771 until the release mechanism 2760 is pierced by the piercing member 2799 or shortly thereafter. To avoid creation of a low-pressure region (e.g., a partial vacuum) within the interior of the reservoir 2750, components of the activation mechanism 2798 relative to the remainder of the applicator device 2770 and the reservoir 2750 can be configured to deliver a suitable volume of gas at a suitable flow rate to the interior of the reservoir 2750 to sufficiently displace liquid from the reservoir 2750 for fluid flow without negative pressure-induced interruption.
In some embodiments, rather than the reservoir being formed as a vial or a cartridge, the reservoir can be formed as a syringe.
The bleeding treatment system 2800 can be the same or similar in structure and/or function to any of the bleeding treatment systems described herein, such as the bleeding treatment system 2400. For example, the bleeding treatment system 2800 includes an applicator device 2870, a pad assembly 2880 including an applicator pad 2810, and a reservoir 2850, which can be the same or similar in structure and/or function to any of the applicator devices, applicator pads, and reservoirs, respectively, described herein. As shown in
The applicator device 2870 includes a first portion 2842 and a second portion 2844. The first portion 2842 and the second portion 2488 may be the same or similar in structure and/or function to any of the first portions and the second portions described herein. The first portion 2842 and the second portion 2844 collectively form an interior space within which at least a portion of the reservoir 2850 can be disposed. As shown in
The first portion 2842 and the second portion 2844 include mating threads such that the second portion 2844 can be twisted relative to the first portion 2842 to advance the second portion 2844 distally relative to the first portion 2842. Although not shown, in some embodiments the second portion 2844 can include features (e.g., laterally extending tabs) to assist a user in rotating the second portion 2844 relative to the first portion 2842. When the reservoir 2850 disposed in the interior space defined by the first portion 2842 and the second portion 2844, the advancement of the second portion 2844 relative to the first portion 2842 can cause an interior proximal surface the second portion 2844 to contact and/or urge the plunger 2858 of the reservoir 2850 distally. Thus, the plunger 2858 and/or the portion of the second portion 2844 configured to contact the plunger 2858 can function as an activation mechanism 2898 that is activatable by rotating the second portion 2844 relative to the first portion 2842. In some embodiments, rather than being coupled via mating threads, the second portion 2844 and the first portion 2842 can be coupled via any suitable mechanism(s) such that the second portion 2844 can be translated or rotated to advance the plunger 2858 relative to the barrel 2854. In some embodiments, the applicator device 2870 can include a spring similarly as described with respect to the applicator device 2470 and be configured such that rotation of the second portion 2844 or movement of another element (e.g., a latch, pin, and/or button) releases the spring such that the spring can apply a distal force to the plunger 2858.
The pad assembly 2880 includes a piercing member 2899. The pad assembly 2880 can also include a plate 2841 coupled to at least a portion of a proximal surface of the applicator pad 2810. The pad assembly 2880 can also include a backing portion 2818 that may be configured as a bandage. The piercing member 2899 can project distally from the applicator pad 2810 such that the release mechanism 2860 can be aligned with the piercing member 2899 (e.g., by handling the grip 2840) and pushed over the piercing member 2899 such that the piercing member 2899 pierces the release mechanism 2860 and allows liquid to flow from the reservoir 2850 through a lumen of the piercing member 2899 and/or outside of the piercing member through one or more openings defined in the plate 2841 to the applicator pad 2810. In some embodiments, the piercing member 2899 can be coupled to the plate 2841. In some embodiments, the piercing member 2899 can be monolithically formed with the plate 2841. The backing portion 2818 can be disposed in contact with a proximal surface of the plate 2841 and can extend away from the plate 2841 and the applicator pad 2810 in two or more opposing directions. The backing portion 2818 can include an adhesive covered pre-use by a peel-away adhesive liner disposed on a distal surface of the backing portion 2818. The adhesive liner can be peeled away prior to placing the backing portion 2818 on a subject's skin so that the backing portion 2818 can be adhered to the skin via the adhesive. The piercing member 2899, the plate 2841, and the backing portion 2818 may be the same or similar in structure and/or function to any of the piercing members, plates, and backing portions, respectively, described herein.
In some embodiments, the reservoir 2850 can include a connector 2881 disposed outside of the neck 2852 and configured to be releasably engaged with a fluid coupling 2855 (also referred to as a connector) of the pad assembly 2880 disposed outside of the piercing member 2899. The fluid coupling 2855 can be formed as a cylindrical structure surrounding the piercing member 2899 and projecting farther from the plate 2841 than the piercing member 2899 to prevent contact between a user (e.g., a user's finger) and the piercing member 2899. The fluid coupling 2855 can optionally be monolithically formed with the plate 2841 and/or the piercing member 2899. The connector 2881 and the fluid coupling 2855 can be configured as mating connectors, such as Luer connectors (as shown in
In use, the user can begin with the system 2800 in an initial configuration (e.g., a packaged configuration) in which the applicator device 2870 is decoupled from the pad assembly 2880. In the initial configuration, the reservoir 2850 can be filled with liquid (e.g., a medication and/or saline) and the plunger 2858 can be in an initial retracted configuration relative to the barrel 2854. To wet the applicator pad 2810, the user can hold the grip 2840 (e.g., one handed), align the release mechanism 2860 with the piercing member 2899 of the pad assembly 2880, and push the release mechanism 2860 over the piercing member 2899 such that the piercing member 2899 breaks the release mechanism 2860. Simultaneously or subsequently, the connector 2881 can optionally be engaged with the fluid coupling 2855 (e.g., by rotating a first Luer mating connector relative to a second Luer mating connector). The second portion 2844 can then be rotated relative to the first portion 2842 (e.g., by a thumb of the user) to advance the second portion 2844 distally, causing the plunger 2858 to be pushed distally relative to the first portion 2842 and the barrel 2854 to urge the liquid from the barrel 2854, through the neck 2852, through the fluid coupling 2855 and/or an optional lumen of the piercing member 2899, and to the applicator pad 2810. The pad assembly 2880 can be coupled to a patient such that the applicator pad 2810 is disposed in contact with a wound of the patient before or after coupling the pad assembly 2880 to the applicator device 2870 and before or after rotating the second portion 2844 to advance the plunger 2858 to wet the applicator pad 2810. After the fluid has been dispensed from the reservoir 2850, the grip 2840 and reservoir 2850 can optionally be decoupled from the pad assembly 2880 as shown in
In some implementations, rather than the piercing member 2899 being coupled to the applicator pad 2810 and releasably couplable to the reservoir 2850, the piercing member 2899 can be coupled to the first portion 2842 similarly as is shown in other applicator devices described herein, such as the applicator device 2570 or the applicator device 2770. The applicator device 2870 could be engaged with the applicator pad 2810 via any suitable connector or via contact between a distal end of the first portion 2842 and the applicator pad 2810.
In some implementations a bleeding treatment system may include an applicator pad filled with a medication.
In some embodiments, the medication M can be stored within the applicator pad 2910, which may be formed from a material containing, absorbing, wicking, or otherwise storing the medication M for application to a surface of the wound. The applicator pad 2910 may include a sponge, a flexible enclosure containing the medication M, and/or the like. In some implementations, the applicator pad 2910 can be formed from a flexible plastic, rubber, gauze, sponge soaked in the medication M, and/or the like.
In some embodiments, the applicator pad 2910 can have a level of saturation (e.g., can be pre-soaked to a saturation level) intended for a particular use of the bleeding treatment system 2900). In some embodiments, the volume and material of the applicator pad 2910 can be selected such that the applicator pad 2910 is about 35% saturated (i.e., contains about 35% of the amount of the medication(s) by volume or by weight). In some embodiments, the applicator pad 2910 can be configured to be between about 30% to and about 60% saturated by volume or by weight by the amount of the medication(s). In some embodiments, the applicator pad 2910 is configured to be between about 25% and about 50% saturated by volume or by weight by the amount of the medication(s). In some embodiments, the applicator pad 2910 may be pre-soaked with medication to about 40% of the saturation point of the applicator pad 2910. Alternatively, in some embodiments, the applicator pad may be pre-soaked with medication to about 50%, about 60%, about 70%, about 80%, or about 90% of the saturation point of the applicator pad 2910.
In some embodiments, the applicator pad 2910 can be pre-soaked or filled to hold a metered dose of medication. In some embodiments, the applicator pad 2910 can be configured such that the volume of medication(s) is effective to treat the wound but such that the medication does not travel across the user's skin outside of the treatment area (e.g., down a user's arm or leg) For instance, the applicator pad 2910 may be formed from material(s) with spatially (e.g., radially) variable saturation by medicine. In an example implementation, the applicator pad 2910 may be more saturated at the central portion of the applicator pad 2910 and less saturated near the perimeter of the applicator pad 2910.
In an example embodiment shown in
The bleeding treatment system 2900 is convenient as it can be readily used at various settings (e.g., at home, hospital, and the like), and during and after various procedures (e.g., the bleeding treatment system 2900 may be applied after surgery, including dermatological surgery such as Mohs micrographic surgery, punch biopsy, shave biopsy, and the like). The bleeding treatment system 2900 may be used post tracheostomy, post laceration repair with sutures as a means to protect the wound and stop bleeding, or after any other procedure that can cause tissue bleeding. Further, the bleeding treatment system 2900 may be used to treat various skin conditions (e.g., melasma, or any other suitable skin conditions). The bleeding treatment system 2900 may be used for patients with a higher risk of bleeding.
While the bleeding treatment system 2900 is shown to have a substantially circular surface of the applicator pad 2910, in some embodiments, any other shape of the applicator pad 2910 may be used (e.g., the bleeding treatment system 2900 may be configured to have different shapes to be used with respect to mucosal membranes including membranes within orifices such as a mouth, nose, ear, rectum, or vagina). The bleeding treatment system 2900 may be used as a therapeutic bandage having different shapes (e.g., circular, rectangular, elliptical, square, cross shape, and the like), and can be placed over user's forehead, cheeks, a nasal bridge, and the like.
In some embodiments, the top surface of the bleeding treatment system 2900 (e.g., the backing portion 2912) can be impermeable to the medication M contained within the applicator pad 2910. In some embodiments, the top surface of the bleeding treatment system 2900 can prevent drying or evaporation of the medication M from the applicator pad 2910.
In some implementations, the applicator pad 2910 may not be pre-soaked with the medication M, but instead the bleeding treatment system 2900 may include a bladder pre-filled with the medication M and adjacent to (or in proximity of) the applicator pad 2910 (e.g., the bladder may be disposed between the backing 2912 of the bleeding treatment system 2900 and the applicator pad 2910). The bladder can be configured to selectively release the medication M to the applicator pad 2910. In some implementations, the bladder can release the medication M to the applicator pad 2910 when it is ruptured due to a pressure applied to the bladder being greater than a threshold pressure (e.g., due to a user pressing on the bladder when the system 2900 is coupled to a wound). In some implementations, the bladder may include a valve that is configured to open when a pressure above a threshold pressure is applied to the bladder, thereby releasing the medication M to the applicator pad 2910.
In some embodiments, at least a bottom portion of the applicator pad 2910 (e.g., a surface of the applicator pad 2910 that is to be placed in contact with a wound of a user) can be covered or enclosed by the removable applicator seal to prevent contamination of the applicator pad 2910 and/or prevent undesired release of any medication(s) that may be contained in the applicator pad 2910. The applicator seal can be formed as a film or other thin layer of material non-reactive with the applicator pad 2910. The applicator seal can be removed from the applicator pad 2910 prior to use (e.g., via peeling) so that the medication M can be delivered to the wound tissue with which the surface of the applicator pad 2910 is placed in contact.
An example of a portion of the bleeding treatment system 3100 is shown in
In some implementations, the DE of the applicator pad 3110 may be configured to be impenetrable to the medication M in at least some regions (e.g., regions between the microneedles 3111, but may be configured to be penetrable to the medication M in proximity of the microneedles 3111). Alternatively, the entirety of the DE may be configured to be penetrable to the medication M. Further, in some implementations, none of the DE may be configured to be penetrable to the medication M, and the medication M may be flowed to a tissue of a user (e.g., a skin of the user) via channels within the microneedles 3111, as further described below.
In various embodiments, using the bleeding treatment system 3100 includes pressing the applicator pad 3110 against the tissue requiring treatment (e.g., the bleeding treatment system 3100 can be pressed against the outer surface of tissue (e.g., the skin) so that the microneedles pierce the skin). The bleeding treatment system 3100 can then be actuated (before or after urging the microneedles through the tissue surface) such that the medication M flows through the applicator pad 3110 and into the pierced holes in the patient to a layer of tissue (e.g., dermis layer) that is deeper than the tissue surface (e.g., skin surface). The actuation includes removing the retaining pin 3144, thereby releasing the activation mechanism 3198.
After releasing the medication M into the tissue, the applicator pad 3110 may be decoupled, disconnected, detached, removed, and the like, from the bleeding treatment system 3100 at a proximal end PE, while being coupled (e.g., attached, adhered, and the like) to a surface of the tissue of the user. In one implementation, similar to various applicator pads described above, the applicator pad 3110 may be adhered to a top surface of the tissue (e.g., to a top surface of user's skin) using any suitable adhering element (e.g., an adhesive bandage). While being attached to the tissue, the microneedles 3111 of the applicator pad 3110 remain attached to a patient for a period of time (as a patch) after the initial attachment/actuation.
The applicator pad 3110 may include any suitable number of microneedles 3111 facilitating transporting the medication M to tissues of a user. For example, the applicator pad 3110 may include a few tens of microneedles or as much as a hundred or a few hundreds of microneedles. In one example, the number of microneedles may be selected such that a characteristic distance between neighboring microneedles is a fraction of a millimeter, about a millimeter, a few millimeters, and the like. In some cases, the distance between the neighboring microneedles may be about the same as a diameter of a microneedle, about a few diameters of a microneedle, or about a few tens of diameters of the microneedle.
The microneedles 3111 may be arranged in any suitable way. For example, the microneedles may be arranged in a rectangular grid, a triangular grid, a hexagonal arrangement, in a form of concentric circles, checkerboard arrangement, or any other suitable periodic or aperiodic arrangements. In the example embodiment, as shown in
In some cases, the applicator pad 3110 may be deformable/compressible so that, as microneedles (e.g., the microneedles 3111) are pushed through the patient's tissue and the applicator pad 3110 contacts a surface of a user's tissue (e.g., a surface of a skin of the user), the applicator pad 3110 retracts relative to the microneedles, thereby exposing more of the length of the microneedles 3111 (so that the microneedles 3111 can be urged deeper in the tissue). For such a configuration, the microneedles 3111 may be attached to the applicator pad 3110 at a top portion of the applicator pad 3110, such that the bottom portion of the applicator pad 3110 can move relative to the microneedles 3111.
When the bleeding treatment system 3100 is actuated to soak the applicator pad 3110 prior to urging the microneedles through the tissue surface and when the applicator pad 3110 is compressible, the retraction of the applicator pad 3110 relative to the microneedles 3111 may also cause medication M in the soaked applicator pad 3110 to be released (e.g., squeezed) from the applicator pad 3110 to contact the tissue surface and flow into the channels formed by the microneedles 3111 piercing the tissue of the user.
Alternatively, in some embodiments, the applicator pad 3110 may be substantially rigid and/or incompressible so that the distance the microneedles 3111 extend beyond the applicator pad 3110 does not change when the bleeding treatment system 3100 is pressed against the user's tissue. For such an embodiment, the distance the microneedles 3111 extend beyond the applicator pad 3110 prior to use of the bleeding treatment system 3100 is equal to the insertion depth of the microneedles 3111.
In some embodiments, the bleeding treatment system 3200 is configured to be used by a single hand of a user (e.g., the subject having a wound or a caregiver of the subject). For example, the bleeding treatment system 3200 may be picked up by a left or a right hand of the user at the first portion 3242 (e.g., wrapping a user's fingers around the first portion 3242 and about a central axis of the first portion), and the applicator pad 3210 may be placed in contact with a wound. The user can translate the first portion 3242 toward the wound by pushing or pulling the first portion 3242 with the user's hand. Sufficient translation of the first portion 3242 relative to the second portion 3244 resulting from translating the first portion 3242 toward the wound causes the applicator pad 3210 to be compressed against the wound, causes compression to be applied to the wound, and causes the system 3200 to transition from an initial, unactuated configuration to an actuated configuration such that fluid (e.g., medication) is delivered to the applicator pad 3210. As the user continues to maintain the applicator pad 3210 against the wound (e.g., compressing the applicator pad 3210), the fluid travels to the wound and/or blood is absorbed from the wound into the applicator pad 3210. In some implementations, the applicator pad 3210 includes a seal that can be removed from the applicator pad 3210 prior to placing the applicator pad 3210 in contact with the wound of the subject.
The bleeding treatment system 3200 includes an applicator release mechanism 3274 located at a top portion within the interior space 3243. The applicator release mechanism 3274 may be configured to move distally (i.e., toward the applicator pad 3210) and relative to the first portion 3242 and the second portion 3244 to push the applicator cap 3212 and the applicator pad 3210 coupled to the applicator cap 3212 from the remainder of the system 3200 (e.g., from the first portion 3242 and the second portion 3242). In some implementations, the applicator release mechanism 3274 may be moved distally due to a distal movement of the cap 3225 (e.g., due to a user pressing on the cap 3225). As can be seen in
The inner housing 3228 is located within the interior space 3243 of the first portion 3242 and is configured to house the springs 3298A and 3298B, the drive plunger 3227, and the reservoirs 3250A and 3250B.
Prior to actuation, the drive plunger 3227 is disposed at a top portion of the inner housing 3228 as shown, for example, in
The drive plunger 3227 houses at least a portion of springs 3298A and 3298B, as shown, for example, in
An upper cap 3228B can be fixedly coupled to the proximal end of the inner housing 3228. The inner housing 3228 retains the reservoirs 3250A and 3250B within an interior of the inner housing 3228 such that the reservoirs 3250A and 3250B are in a fixed position relative to the inner housing 3228 (and, thus, are in a fixed position relative to the first portion 3242). In some implementations, rather than including two reservoirs, the system 3200 can include only one reservoir. Each reservoir 3250A and 3250B has an open distal end closed by a release mechanism 3260 (e.g., a pierceable membrane such as a cap or cover). In the initial configuration of the system 3200, the release mechanisms 3260 can be disposed proximal of the piercing members 3299. In the actuated configuration of the system 3200, the piercing members 3299 can pierce the release mechanisms 3260 to release fluid from the reservoirs 3250.
The reservoirs 3250A and 3250B may be made from a transparent material (e.g., glass, transparent plastic, and the like), and the inner housing 3228 may include transparent windows 3241A and 3241A through which the reservoirs 3250A and 3250B can be viewed to observe the operation of the system 3200 (e.g., to determine the amount of fluid remaining within the reservoirs 3250A and 3250B). In some cases, the windows 3241A and 3241B may include markings indicating the volume of medicine remaining with the reservoirs 3250A and 3250B based on the visible location of the pistons 3251A and 3251B. Alternatively, the reservoirs 3250A and 3250B may include markings, and windows 3241A and 3241B may be openings defined by the inner housing 3228. The windows 3241A and 3241B may be disposed within openings 3242A and 3242B defined within the first portion 3242, as shown in
The inner housing 3228 can include flexible detents (e.g., a flexible detent 3271F is shown in
The protrusions 3275A and 3275B are configured to be translated along the walls of the inner housing 3228 in response to the first portion 3242 being translated distally relative to the second portion 3244, causing an activation action of springs 3298A and 3298B. For example, the sliding of the protrusions 3275A and 3275B proximally relative to the first portion 3242 causes movement of the flexible detents (as further described below in connection to
The actuator slider 3275 is coupled to the fluid coupler carrier 3244 via coupling elements 3278, which can be screws, rivets, or any other suitable coupling elements for fixedly attaching the actuator slider 3275 to the fluid coupler carrier 3244. In some implementations, rather than being separate components, the actuator slider 3275 and the fluid coupler carrier 3244 may be monolithically formed from any suitable material (e.g., plastic, metal, composite material, ceramics, glass, and the like).
The fluid coupler carrier 3244 is disposed within a distal end of the first portion 3242 and is configured to slide proximally relative to the first portion 3242 and the inner housing 3228 when a user presses the applicator pad 3210 onto a wound. Further, the actuator slide 3275 being fixedly attached to the fluid coupler carrier 3244 is also configured to slide proximally by the same distance as the fluid coupler carrier 3244.
The second portion 3244 includes fixedly attached piercing members 3299A and 3299B. In some implementations, the piercing members 3299A and 3299B can form fluid couplings and may be formed as hollow needles such that the piercing members 3299A and 3299B define channels between the respective reservoirs 3250A and 3250B and the applicator pad 3210 when the second portion 3244 is translated proximally relative to the first portion 3242. In some implementations, the distal ends of the piercing members 3299A and 3299B can be disposed within openings defined in the backing portion 3212 and/or can be coupled to the applicator pad 3210, and the proximal ends of the piercing members 3299A and 3299B can be configured to puncture release mechanisms of respective reservoirs 3250A and 3250B when the fluid coupler carrier 3244 slides proximally relative to the first portion 3242 (e.g., the piercing members 3299A and 3299B may be each positioned below the release mechanisms 3260 of respective reservoirs 3250A and 3250B). In some embodiments, the number of fluid couplings can correspond to the number of fluid reservoirs. For example, if in an implementation a single reservoir is used, then a single fluid coupling (e.g., piercing member) can be employed for forming a channel between the reservoir and the applicator pad 3210. If more than two reservoirs are used, then more than two fluid couplings (e.g., piercing members) can be employed.
The second portion 3244 can include a first set of detents configured to couple (e.g., via a snap fit) to the inner housing 3228 after sliding proximally relative to the first portion 3242, thereby preventing the second portion 3244 from sliding back distally relative to the first portion 3242. Additionally, or alternatively, the second portion 3244 may include another (e.g., second) set of detents for coupling (e.g., via snap fit) to a distal portion of the first portion 3242, thereby preventing the second portion 3244 from sliding back distally relative to the first portion 3242. Further, after moving the second portion 3244 proximally relative to the first portion 3242 and engaging the first set of detents to couple to the inner housing 3228 and/or the second set of detents to couple to the distal portion of the first portion 3242, a tactile and audible feedback may be delivered to the user indicating that the bleeding treatment system 3200 is activated.
The second portion 3244 can be coupled to the applicator cap 3212. The applicator cap 3212 can be snap fit to the second portion 3244. The applicator cap 3212 includes a proximal side adjacent to the second portion 3244 and a distal side adjacent to the applicator pad 3210. Further, the applicator cap 3212 defines openings through which the piercing members 3299A and 3299B can be disposed and/or with which the piercing members 3299A and 3299B can be aligned such that fluid can flow from the reservoirs 3250 to the applicator pad 3210 via the openings in the applicator cap 3212. The applicator cap 3212 may be decoupled from the second portion 3244 by applying a sufficient force onto the proximal side of the applicator cap 3212, thereby pushing the applicator cap 3212 from the second portion 3244. In some implementations, the second portion 3244 can be coupled to the slider 3275, which includes a base plate including openings 3276C and 3276D through which respective protrusions 3274C and 3274D are configured to translate into contact with the proximal side of the applicator cap 3212 when the applicator release mechanism 3274 moves distally relative to the first portion 3242. The exerted force by protrusions 3274C and 3274D can cause the applicator cap 3212 to decouple from the second portion 3244.
As shown in
In some embodiments, the applicator pad 3210 can be configured to fit within the interior space defined by the applicator cap 3212. In some embodiments, the applicator pad 3210 may be formed as, or include, a sponge, which can be compressed when it is inserted within the applicator cap 3212 and/or when the applicator pad 3210 is pressed against a patient surface using the system 3200 is pressed against a patient surface.
As shown in
The drive plunger 3327 can include a pair of plunger members 3327A (also referred to as plunger elements), each plunger member 3327A configured to be translated within the channels defined by the inner support frame 3328 to engage with respective reservoir 3350 of the pair of reservoirs 3350. For example, the reservoirs can be formed as cartridges including a reservoir housing (e.g., a barrel), a piston 3351 closing a proximal end of the reservoir housing, and a release mechanism 3360 (e.g., a pierceable membrane in the form of a cap or cover) closing a distal end of the reservoir housing. The drive plunger 3327 can be translated distally (e.g., within the inner support frame 3328) to urge each plunger member 3327A into engagement with a piston 3351 of each reservoir 3350 to advance the piston 3351 relative to a housing of each reservoir 3350 and urge fluid from the reservoir 3350.
As shown in
The second housing portion 3344 also defines a pair of openings configured to receive the piercing members 3399 such that the needles are fixed within the openings and extend proximally from the openings. Each of the piercing members 3399 can have a sharp proximal end and a blunt distal end that does not contact any components other than the second housing portion 3344 during operation of the system 3300. The second housing portion 3344 is also configured to be coupled to the pair of elongated members 3329 such that the pair of elongated members 3329 extend proximally from the second housing portion 3344 and are fixed relative to the second housing portion 3344 such that translation of the lower actuator subassembly 3304 translates the pair of elongated members 3329. Each of the elongated members defines a recessed portion 3329A.
As shown in
As shown in
The spring elements 3398 can be disposed such that a proximal end of each spring is in contact with a distal-facing surface of the base portion 3374A and a distal end of each spring element 3398 is in contact with a proximal-facing surface of the drive plunger 3327 such that actuation of the system 3300 (e.g., via translating the second housing portion 3344 proximally relative to the first housing portion 3342 to cause the drive plunger 3327 to be released from an initial position) causes the spring elements 3398 to transition from a stored energy configuration to an activated configuration (e.g., from a compressed to an expanding and/or expanded configuration) to drive the drive plunger 3327 distally (e.g., to urge the pistons 3351 of the reservoirs 3350 distally). In some embodiments, the actuation of the system 3300 can also cause (e.g., simultaneously or immediately before or after) the button 3325 to be transitioned to an actuated position from an initial position (e.g., translated proximally relative to the first housing portion 3342) due to the proximal end of the spring elements 3398 applying a proximal force to the base portion 3374A and/or the button 3325 such that the button 3325 can be pressed distally by the user to urge the elongated members 3398 into urging contact with the backing 3312 to urge the applicator pad 3310 and the backing 3312 away from the second housing portion 3344.
In some embodiments, the cap 3320 can include two cap halves coupled together via a flexible or living hinge. Thus, the cap 3320 can be separated from the distal end of the remainder of the system 3320 via bending or rotating one half relative to the other half of the cap 3320.
The bleeding treatment system 3400 can be the same or similar in structure and/or function to any of the bleeding treatment systems disclosed herein. For example, the bleeding treatment system 3400 can include a grip 3440 including a first housing 3442 (also referred to as a first housing portion) and a second housing 3444 (also referred to as a second housing portion). The bleeding treatment system 3400 can also include an applicator pad 3410, a pair of reservoirs 3450, and an actuation mechanism 3498 (also referred to as an energy storage member or element).
As shown in
The applicator pad 3410 can be the same or similar in structure and/or function to any of the applicator pads described herein. In some embodiments, the applicator pad can have a thickness of between about ⅛ inch and about 1 inch, between about, ¼ inch and about 6/8 inch, between about ¼ inch and about ½ inch, about ⅝ inch, and/or about ¼ inch. In some embodiments, the applicator pad 3410 can have any suitable diameter, such as about 42 mm. In some embodiments, the applicator pad 3410 can be configured to have any suitable fluid capacity in an uncompressed configuration of the applicator pad 3410 (e.g., about 36 mL, about 30 mL, about 40 mL, between about 30 and 40 mL, between about 20 and 50 mL, between about 20 and 20 mL, and/or between about 10 and 30 mL). In some embodiments, the applicator pad 3410 can be configured to be about 80%, about 70%, about 60%, about 90%, about 70-90%, and/or any other suitable percentage saturated by the fluid when compressed (e.g., against a surface or wound of a user) and the fluid is fully dispensed to the applicator pad 3410. In some embodiments, when compressed, the applicator pad 3410 can be configured to have a fluid capacity of, for example, 3 mL, 4 mL, 5 mL, 6 mL, 7 mL, 8 mL, 9 mL, 10 mL, and/or any suitable range such as a range bounded by or containing these example volumes. For example, in some embodiments, the applicator pad 3410 can have a 7 mL capacity for 100% saturation and/or a 6 mL capacity for an 85% compressed saturation or 17% uncompressed saturation. The applicator pad 3410 can be configured to absorb blood from the wound while receiving, containing and/or dispensing the fluid from the reservoir 3450 to the wound.
The first housing portion 3442 can define an interior space and an open distal end. As shown, in some implementations the first housing portion 3442 can have a central axis, an elongated portion 3442X, and a base portion 3442W disposed distally of the elongated portion 3442X and having a greater lateral extent relative to the central axis than the elongated portion 3442X. The base portion 3442W can define the open distal end, the elongated portion 3442X can define a first portion of the interior space, and the base portion 3442W can define a second portion of the interior space. The first housing portion 3442 can also define an open proximal end or an opening in the proximal end within which the ejection button 3425 can be disposed. The first housing portion 3442 (e.g., the elongated portion 3442X) can also define at least one sidewall opening 3441A (e.g., two sidewall openings) such that at least one of the reservoirs 3450 can be viewed by a user through the sidewall openings 3441A. The first housing portion 3442 can include a transparent window segment disposed within each of the sidewall openings 3441A. In some implementations, the sidewall openings 3441A can be sufficiently long such that a majority of or the entire length of each reservoir 3450 and/or of a travel path of a piston of each reservoir 3450 can be viewed through the sidewall openings 3441A. The first housing portion 3442 can optionally include a gripping texture, such as ribs, disposed on the outer surface of the first housing portion 3442 (e.g., an outer surface of the elongated portion 3442X) to improve the grip of the user.
In some embodiments, each of the components of the system 3400 disposed within the interior space of the first housing portion 3442 can optionally include stabilizing portions (e.g., elongated members) for guiding, stabilizing, and/or supporting movement of the component within the interior space of the first housing portion 3442 (e.g., within voids formed by other components of the system 3400). For example, the applicator pad release mechanism 3474 can include stabilizing portions 3474z. Additionally, in some embodiments, the base portion 3442W, a proximal surface of the base portion 3442W, a portion of the second housing portion 3444 (e.g., a planar surface or portion), a distal surface of the inner housing 3428, and/or a proximal or substantially planar surface of the backing portion 3412 can function separately or collectively as a force distribution plate as described with respect to other embodiments herein.
The second housing portion 3444 can be configured to be at least partially disposed in the interior space of the first housing portion 3442 (e.g., at least partially disposed in the interior space of the base portion 3442W).
As shown in
The backing portion 3412 can include a proximal wall and sidewalls collectively defining an interior space configured to receive at least a portion of the applicator pad 3410. As shown in
The backing portion 3412 can be coupled to the applicator pad 3410 via any suitable coupling mechanism. For example, the applicator pad 3410 can be coupled to the backing portion 3412 via a friction fit and/or adhesive. In some embodiments, adhesive can be disposed between the applicator pad 3410 and an inner surface of the sidewall of the backing portion 3412. In some embodiments, alternatively or in addition, adhesive can be disposed between the proximal surface of the applicator pad 3410 and the distal surface of the backing portion 3412.
In some embodiments, as shown in
The backing portion 3412 can be formed of any suitable material, and can be flexible or rigid. For example, the backing portion 3412 can include webbing features for improved structural integrity (e.g., disposed around a perimeter of a proximal surface of the backing portion 3412), and can optionally have fewer or no webbing features in a central area of the backing portion 3412 to improve flexibility of the backing portion 3412. In some embodiments, the backing portion 3412 can be formed of thermoplastic polyurethane (TPU) and/or polypropylene (PP). In some embodiments, some portions of the backing portion 3412 can be displaced relative to other portions via a user pressing on the proximal side of the backing portion 3412 such that a user can control compression of the backing portion 3412 and the applicator pad 3410 (e.g., compression of a particular portion of the applicator pad being greater than another portion of the applicator pad) relative to the wound when the backing portion 3412 and the applicator pad 3410 are decoupled from the remainder of the system 3400.
The reservoirs 3450 can each be formed as a cartridge including a rigid housing (e.g., a barrel) defining an interior configured to be prefilled with a medication (e.g., liquid). Each reservoir 3450 can have a distal open end closed by the release mechanism 3460 (e.g., a pierceable membrane formed as a cap or cover) and a proximal open end closed by a movable piston 3451. The release mechanism 3460 can be the same or similar in structure and/or function to any of the release mechanisms described herein (e.g., the release mechanism 2360). In the initial configuration of the system 3400, the movable piston 3451 is located at a proximal end of the housing of the reservoir 3450, as shown in
Each piercing member 3499 defines a lumen through which liquid can flow from the reservoir toward the applicator pad 3410. As shown in
Due to the piercing members 3499 being fixedly coupled to the second housing portion 3444 and the reservoirs 3450 being retained in a fixed position relative to the first housing portion 3442, translation of the first housing portion 3442 distally relative to the second housing portion 3444 can cause the piercing members 3499 to piercingly contact the release mechanisms 3460 of the reservoir 3450 to allow fluid to flow from the reservoirs 3450 to the applicator pad 3410 via the piercing members 3499 and the openings in the backing portion 3412.
The pair of pad-urging elongated members 3426 can be coupled to the ejection button 3425 (e.g., via the base portion 3474A of the ejection subassembly 3406) and extend distally thereof. Each elongated member 3426 can include a retention element 3426A (e.g., a hook or latch) configured to selectively mate with a complementary retention element 3444K of the second housing portion 3444. In some embodiments, as shown, the retention element 3426A can be formed of a reduced thickness portion of the elongated member 3426 and a hook or latch element disposed on the distal end of the reduced thickness portion of the elongated member 3426 such that a recess is formed in the elongated member 3426. As shown in
The distal end 3426B of each elongated member 3426 (e.g., the distal end 3426B of the retention element 3426A) can be configured to mate with an ejection feature 3412F of the backing portion 3412 (e.g., a hub surrounding recess or opening and/or a raised or non-raised portion of the proximal surface 3412D of the backing portion 3412). Thus, as shown in
As shown in
In use, a user (e.g., the subject or a caregiver) can use the system 3400 using the same or similar method steps as described with respect to any of the other systems and methods herein. For example, the user can remove the optional cap 3420 and place the absorbent pad 3410 in contact with a wound of the subject in the initial, unactuated state. The user can then translate the first housing portion 3442 distally toward the wound a sufficient distance to compress the absorbent pad 3410 against the wound and to cause the first housing portion 3442 to advance a sufficient distance (e.g., from a first position to a second position) relative to the second housing portion 3444 to cause the system 3400 to actuate. In some embodiments, the amount of actuation force applied to actuate the system 3400 (e.g., to translate the first housing portion 3442 from the first position to the second position) can be less than 2 N, between about 5 N and about 15 N, between about 2N and about 20 N, or any other suitable amount of force. The relative translation of the first housing portion 3442 and the second housing portion 3442 can cause the actuation mechanism 3498 to be actuated such that the springs apply pressure to the pistons of the reservoirs 3450 and (e.g., simultaneously or immediately before or after) can cause the piercing members 3499 to pierce the release mechanisms 3460 of the reservoirs 3450 such that a fluid coupling is established from the reservoirs 3450 to the applicator pad 3410 and fluid is urged through the fluid coupling by the drive plunger 3427 under control of the actuation mechanism 3498 (e.g., springs). In some embodiments, simultaneously or immediately before or after the actuation of the actuation mechanism 3498 and piercing of the release mechanisms 3460, the ejection button 3425 can also be urged proximally as a result of the relative movement of the first housing portion 3442 and the second housing portion 3444. The user can maintain the applicator pad 3410 against the wound for a period of time sufficient for the fluid to be dispensed to the applicator pad 3410 by continuing to grip the first housing portion 3442 (e.g., with fingers wrapped around the elongated portion 3442X) and pressing or pulling the first housing portion 3442 against the wound such that the applicator pad 3410 remains compressed. In some embodiments, the fluid can be dispensed to the applicator pad 3410 in a period of time of about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, or within a range of time of about 3-10 seconds, of about 10-30 seconds, of about 20-30 seconds, of about 20-30 seconds, of about 5 seconds to about 30 seconds, of about 10 seconds to about 60 seconds, or any suitable amount or range of time. In some embodiments, the user can observe movement of the piston 3451 and/or plunger 3427A relative to the reservoir housing of the reservoir 3450 through the window 3441A of the first housing portion 3442 and evaluate whether the system 3400 is functioning properly and/or determine when the fluid has been fully dispensed.
Similarly as described with respect to other method steps described herein, the user can maintain the applicator pad 3410 against the wound for a period of time (e.g., a period of time sufficient to achieve hemostasis) by continuing to grip the first housing portion 3442 (e.g., with fingers wrapped around the elongated portion 3442X) and pressing or pulling the first housing portion 3442 against the wound such that the applicator pad 3410 remains compressed. The period of time can optionally be based on when the fluid was observed to be fully dispensed through the window 3441A. After a period of time, the user can check the wound and/or remove the applicator pad 3410 from the wound to discontinue use of the grip 3440. Optionally, the user can eject the applicator pad 3410 and backing portion 3412 from the remainder of the system 3400 (e.g., from the grip 3440) by pressing the ejection button 3425 distally (e.g., toward the second housing portion), causing the elongated members 3426 to apply a force to the backing portion 3412 to urge the backing portion 3412 and the applicator pad 3410 to separate from the second housing portion 3444 and be released from the grip 3440. Optionally, the applicator pad 3410 and the backing portion 3412 can then be applied to the wound for a period of time (e.g., by holding the applicator pad 3410 and backing portion 3412 against the subject with a hand or by placing the applicator pad 3410 against the wound and applying a bandage or wrap to the backing portion 3412 to secure the applicator pad 3410 and the backing portion 3412 relative to the wound).
While various embodiments have been described herein, textually and/or graphically, it should be understood that they have been presented by way of example only, and not limitation. Likewise, it should be understood that the specific terminology used herein is for the purpose of describing particular embodiments and/or features or components thereof and is not intended to be limiting. Various modifications, changes, enhancements, and/or variations in form and/or detail may be made without departing from the scope of the disclosure and/or without altering the function and/or advantages thereof unless expressly stated otherwise. Functionally equivalent embodiments, implementations, and/or methods, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing descriptions and are intended to fall within the scope of the disclosure.
Where schematics, embodiments, and/or implementations described above indicate certain components arranged and/or configured in certain orientations or positions, the arrangement of components may be modified, adjusted, optimized, etc. The specific size and/or specific shape of the various components can be different from the embodiments shown and/or can be otherwise modified, while still providing the functions as described herein. More specifically, the size and shape of the various components can be specifically selected for a desired or intended usage. Thus, it should be understood that the size, shape, and/or arrangement of the embodiments and/or components thereof can be adapted for a given use unless the context explicitly states otherwise. By way of example, in some implementations, a treatment device intended to provide treatment to an adult user may have a first size and/or shape, while a treatment device intended to provide treatment to a pediatric user may have a second size and/or shape smaller than the first size and/or shape. Moreover, the smaller size and/or shape of, for example, a pediatric treatment device may result in certain components being moved, reoriented, and/or rearranged while maintaining the desired function of the device.
Although various embodiments have been described as having particular characteristics, functions, components, elements, and/or features, other embodiments are possible having any combination and/or sub-combination of the characteristics, functions, components, elements, and/or features from any of the embodiments described herein, except mutually exclusive combinations or when clearly stated otherwise. Moreover, unless otherwise clearly indicated herein, any particular combination of components, functions, features, elements, etc. can be separated and/or segregated into independent components, functions, features, elements, etc. or can integrated into a single or unitary component, function, feature, element, etc.
Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. While methods have been described as having particular steps and/or combinations of steps, other methods are possible having a combination of any steps from any of methods described herein, except mutually exclusive combinations and/or unless the context clearly states otherwise.
This application is a continuation of International Patent Application No. PCT/US2023/063606, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed Mar. 2, 2023, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 63/315,915, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Mar. 2, 2022, the disclosure of each of which is incorporated by reference herein in its entirety. International Patent Application No. PCT/US2023/063606 is a continuation-in-part of U.S. patent application Ser. No. 17/728,894, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Apr. 25, 2022, which is a divisional of U.S. patent application Ser. No. 17/522,736, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Nov. 9, 2021, which is a continuation of International PCT Application No. PCT/US2021/053641, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Oct. 5, 2021, which is a continuation-in-part of International PCT Application No. PCT/US2021/026714, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Apr. 9, 2021, which claims priority to U.S. Provisional Patent Application Ser. No. 63/007,543, entitled “Devices for Bleeding Reduction and Methods of Making and Using the Same,” filed on Apr. 9, 2020, the disclosure of each of which is incorporated by reference herein in its entirety. International PCT Application No. PCT/US2021/053641 also claims priority to U.S. Provisional Patent Application Ser. No. 63/087,532, entitled “Methods for Self-Treatment or Home Care Provider Treatment of Minor Wounds,” filed on Oct. 5, 2020, and U.S. Provisional Patent Application Ser. No. 63/090,768, entitled “Methods for Self-Treatment or Care Provider Treatment of Minor Wounds,” filed on Oct. 13, 2020, the disclosure of each of which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63315915 | Mar 2022 | US | |
| 63087532 | Oct 2020 | US | |
| 63090768 | Oct 2020 | US | |
| 63007543 | Apr 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17522736 | Nov 2021 | US |
| Child | 17728894 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2023/063606 | Mar 2023 | WO |
| Child | 18821990 | US | |
| Parent | PCT/US2021/053641 | Oct 2021 | WO |
| Child | 17522736 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17728894 | Apr 2022 | US |
| Child | PCT/US2023/063606 | US | |
| Parent | PCT/US2021/026714 | Apr 2021 | WO |
| Child | PCT/US2021/053641 | US |
